Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 24, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | DVAX | ||
Entity Registrant Name | Dynavax Technologies Corp | ||
Entity Central Index Key | 0001029142 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 124,921,757 | ||
Entity Public Float | $ 1 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-34207 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 33-0728374 | ||
Entity Address, Address Line One | 2100 Powell Street | ||
Entity Address, Address Line Two | Suite 900 | ||
Entity Address, City or Town | Emeryville | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94608 | ||
City Area Code | 510 | ||
Local Phone Number | 848-5100 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | true | ||
Documents Incorporated by Reference | Portions of the Definitive Proxy Statement for the registrant’s 2022 Annual Meeting of Stockholders are incorporated by reference into Part III, Items 10-14 of this Form 10-K. The Definitive Proxy Statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2021. | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | San Francisco, California | ||
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 436,189 | $ 32,073 |
Marketable securities available-for-sale | 109,761 | 132,963 |
Other receivables | 15,600 | 356 |
Inventory | 61,335 | 63,689 |
Prepaid manufacturing | 159,655 | 29,423 |
Prepaid expenses and other current assets | 73,764 | 9,206 |
Total current assets | 972,520 | 290,015 |
Property and equipment, net | 35,020 | 30,567 |
Operating lease right-of-use assets | 25,964 | 26,583 |
Goodwill | 2,125 | 2,297 |
Restricted cash | 219 | 237 |
Other assets | 3,398 | 3,573 |
Total assets | 1,039,246 | 353,272 |
Current liabilities: | ||
Accounts payable | 2,600 | 3,312 |
Accrued research and development | 4,688 | 2,805 |
CEPI accrual | 128,848 | 0 |
Accrued liabilities (see Note 7) | 49,796 | 19,099 |
Warrant liability | 18,016 | 10,736 |
Deferred revenue | 349,864 | 38,212 |
Other current liabilities | 2,590 | 3,247 |
Total current liabilities | 556,402 | 77,411 |
Long-term debt, net of debt discounts of $1,094 and $1,394 at December 31, 2020 and 2019, respectively | 0 | 179,811 |
Convertible Notes, net of debt discount of $5,010 at December 31, 2021 (see Note 10) | 220,490 | 0 |
Long-term portion of lease liabilities | 34,316 | 34,789 |
Other long-term liabilities | 5,664 | 2,568 |
Total liabilities | 816,872 | 294,579 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Preferred stock: $0.001 par value | ||
Common stock: $0.001 par value; 278,000 shares authorized at December 31, 2021 and 2020; 122,945 shares and 110,190 shares issued and outstanding at December 31, 2021 and 2020, respectively | 123 | 110 |
Additional paid-in capital | 1,441,868 | 1,352,374 |
Accumulated other comprehensive gain (loss) | (2,266) | 273 |
Accumulated deficit | (1,217,351) | (1,294,064) |
Total stockholders’ equity | 222,374 | 58,693 |
Total liabilities and stockholders’ equity | 1,039,246 | 353,272 |
Series B Convertible Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock: $0.001 par value | ||
Trade Accounts Receivable [Member] | ||
Current assets: | ||
Accounts receivables, net | $ 116,216 | $ 22,305 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Long-term debt, net of debt discount | $ 5,010 | $ 1,094 |
Preferred stock, par value | $ 0.001 | |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value | $ 0.001 | |
Common stock, shares authorized | 278,000,000 | 278,000,000 |
Common stock, shares issued | 122,945,000 | |
Common stock, shares outstanding | 122,945,357 | 110,190,000 |
Series B Convertible Preferred Stock | ||
Preferred stock, shares issued | 0 | 4,000 |
Preferred stock, shares outstanding | 0 | 4,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | |||
Total revenues | $ 439,442,000 | $ 46,551,000 | $ 35,219,000 |
Operating expenses: | |||
Cost of sales - product | 173,572,000 | 11,410,000 | 10,172,000 |
Cost of sales - amortization of intangible assets | 0 | 2,500,000 | 9,217,000 |
Research and development | 32,228,000 | 28,607,000 | 62,331,000 |
Selling, general and administrative | 100,156,000 | 79,256,000 | 74,986,000 |
Gain on sale of assets | (1,000,000) | (6,851,000) | 0 |
Restructuring | 0 | 0 | 13,356,000 |
Total operating expenses | 304,956,000 | 114,922,000 | 170,062,000 |
Income (loss) from operations | 134,486,000 | (68,371,000) | (134,843,000) |
Other income (expense): | |||
Interest income | 140,000 | 1,260,000 | 3,370,000 |
Interest expense | (11,176,000) | (19,062,000) | (16,977,000) |
Sublease income | 7,735,000 | 7,706,000 | 2,619,000 |
Loss on debt extinguishment | (5,232,000) | 0 | 0 |
Change in fair value of warrant liability (Note 14) | (49,354,000) | 4,124,000 | (7,500,000) |
Other | 922,000 | (897,000) | 731,000 |
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest, Total | 77,521,000 | (75,240,000) | (152,600,000) |
Provision for income taxes | (808,000) | 0 | 0 |
Net income (loss) | 76,713,000 | (75,240,000) | (152,600,000) |
Undistributed earnings allocated to participating securities | (4,569,000) | 0 | 0 |
Preferred stock deemed dividend | 0 | 0 | (3,267,000) |
Net income (loss) allocable to common stockholders, basic | $ 72,144,000 | $ (75,240,000) | $ (155,867,000) |
Basic net loss per share allocable to common stockholders | $ 0.62 | $ (0.75) | $ (2.16) |
Diluted net loss per share allocable to common stockholders | $ 0.57 | $ (0.78) | $ (2.16) |
Weighted average shares used to compute basic net loss per share allocable to common stockholders | 116,264 | 100,753 | 72,024 |
Weighted average shares used to compute diluted net loss per share allocable to common stockholders | 133,006 | 101,504 | 72,024 |
Product | |||
Revenues: | |||
Total revenues | $ 437,099,000 | $ 39,307,000 | $ 34,644,000 |
Other Revenue | |||
Revenues: | |||
Total revenues | $ 2,343,000 | $ 7,244,000 | $ 575,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Net income (loss) | $ 76,713 | $ (75,240) | $ (152,600) |
Other comprehensive income (loss), net of tax: | |||
Reclassification of realized gain on available-for-sale securities recognized in interest income | (21) | ||
Change in unrealized gain on marketable securities available-for-sale | (30) | (20) | 140 |
Cumulative foreign currency translation adjustments | (2,509) | 2,701 | (512) |
Total other comprehensive income (loss) | (2,539) | 2,660 | (372) |
Total comprehensive loss | $ 74,174 | $ (72,580) | $ (152,972) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Series B Convertible Preferred Stock | Common Stock | Preferred Stock | Preferred StockSeries B Convertible Preferred Stock | Additional Paid-in Capital | Additional Paid-in CapitalSeries B Convertible Preferred Stock | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Beginning Balances at Dec. 31, 2018 | $ 63,065 | $ 63 | $ 1,131,241 | $ (2,015) | $ (1,066,224) | ||||
Beginning Balances (in shares) at Dec. 31, 2018 | 62,862,000 | ||||||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net | (2) | $ 1 | (1) | ||||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares) | 975,000 | ||||||||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement (Shares) | 19,912,000 | 5,000 | |||||||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement | 60,113 | $ 12,061 | $ 20 | 60,093 | $ 12,061 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 565 | 565 | |||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 122,000 | ||||||||
Stock compensation expense | 25,456 | 25,456 | |||||||
Total other comprehensive loss | (372) | (372) | |||||||
Net income (loss) | (152,600) | (152,600) | |||||||
Ending Balances at Dec. 31, 2019 | 8,290 | $ 84 | 1,229,417 | (2,387) | (1,218,824) | ||||
Ending Balances (in shares) at Dec. 31, 2019 | 83,871,000 | 5,000 | |||||||
Conversion of Preferred Stock | 1 | $ 1 | |||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | 700,000 | ||||||||
Stock Redeemed During Period, Shares, Conversion of Convertible Securities (in shares) | (1,000) | ||||||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net | 289 | $ 1 | 288 | ||||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares) | 1,209,000 | ||||||||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement (Shares) | 24,215,000 | ||||||||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement | 108,537 | $ 24 | 108,513 | ||||||
Issuance of common stock under Employee Stock Purchase Plan | 672 | 672 | |||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 195,000 | ||||||||
Stock compensation expense | 13,484 | 13,484 | |||||||
Total other comprehensive loss | 2,660 | 2,660 | |||||||
Net income (loss) | (75,240) | (75,240) | |||||||
Ending Balances at Dec. 31, 2020 | 58,693 | $ 110 | 1,352,374 | 273 | (1,294,064) | ||||
Ending Balances (in shares) at Dec. 31, 2020 | 110,190,000 | 4,000 | |||||||
Conversion of Preferred Stock | $ 4 | (4) | |||||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | 4,140,000 | ||||||||
Stock Redeemed During Period, Shares, Conversion of Convertible Securities (in shares) | 4,000 | ||||||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net | 6,577 | $ 2 | 6,575 | ||||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares) | 1,560,000 | ||||||||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement (Shares) | 2,879,000 | ||||||||
Issuance of common stock, net of issuance costs, in conjunction with an underwritten public offering and an At Market Sales Agreement | 28,156 | $ 3 | 28,153 | ||||||
Issuance of common stock under Employee Stock Purchase Plan | 841 | 841 | |||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 217,000 | ||||||||
Issuance of common stock upon exercise of warrants (Shares) | 3,959,000 | ||||||||
Issuance of common stock upon exercise of warrants | 59,888 | $ 4 | 59,884 | ||||||
Issuance of capped call options (see Note 10) | (27,240) | (27,240) | |||||||
Stock compensation expense | 21,285 | 21,285 | |||||||
Total other comprehensive loss | (2,539) | (2,539) | |||||||
Net income (loss) | 76,713 | 76,713 | |||||||
Ending Balances at Dec. 31, 2021 | $ 222,374 | $ 123 | $ 1,441,868 | $ (2,266) | $ (1,217,351) | ||||
Ending Balances (in shares) at Dec. 31, 2021 | 122,945,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities | |||
Net income (loss) | $ 76,713 | $ (75,240) | $ (152,600) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |||
Depreciation and amortization | 4,296 | 4,273 | 8,938 |
Amortization of right-of-use assets | 2,715 | 2,562 | 3,375 |
Inventory write-off | 2,588 | ||
Loss (gain) on disposal of property and equipment and from lease termination | 47 | (98) | 18 |
Amortization of premiums (accretion of discounts) on marketable securities | 470 | 535 | (1,462) |
Realized gain on available-for-sale securities | 57 | ||
Loss on debt extinguishment | (5,232) | 0 | 0 |
Change in fair value of warrant liability | 49,354 | (4,124) | 7,500 |
Stock compensation expense | 21,285 | 13,484 | 25,456 |
Cost of sales - amortization of intangible assets | 0 | 2,500 | 9,217 |
Non-cash interest expense | 1,608 | 2,542 | 4,973 |
Tenant improvements provided by the landlord | (1,137) | (6,999) | |
Gain on sale of assets | (1,000) | (6,851) | 0 |
Changes in operating assets and liabilities: | |||
Accounts and other receivables, net | (109,155) | (13,775) | (5,182) |
Inventories, net | (234) | 22,357 | 22,310 |
Prepaid manufacturing | (130,232) | (29,423) | |
Prepaid expenses and other current assets | (64,558) | (1,826) | (1,278) |
Other assets | 175 | (229) | 1,632 |
Accounts payable | (767) | (3,448) | 4,848 |
CEPI accrual (see Note 9) | 128,848 | ||
Lease liabilities | 3,234 | 2,872 | 2,000 |
Deferred revenue | 311,652 | 38,212 | |
Accrued and other liabilities | 39,725 | 2,804 | (9,376) |
Net cash provided by (used in) operating activities | 335,528 | (92,251) | (121,252) |
Investing activities | |||
Acquisition of technology licenses | 7,000 | 7,000 | |
Purchases of marketable securities | (164,928) | (201,786) | (215,191) |
Proceeds from maturities and redemptions of marketable securities | 187,630 | 148,565 | 201,810 |
Proceeds from sales of marketable securities | 30,910 | ||
Purchases of property and equipment, net | (9,477) | (4,072) | (22,401) |
Proceeds from sale of assets, net of transaction costs | 1,000 | 6,851 | |
Net cash (used in) provided by investing activities | 14,225 | (26,532) | (42,782) |
Financing activities | |||
Proceeds from long-term debt, net | 74,250 | ||
Proceeds from issuances of common stock, net | 28,156 | 108,538 | 65,948 |
Proceeds from issuances of preferred stock, net | 13,586 | ||
Proceeds from issuance of Convertible Notes, net | 219,822 | ||
Purchases of capped call options | 27,240 | ||
Repayment of long-term debt | 190,194 | ||
Proceeds from Issuance of Warrants | 17,814 | ||
Proceeds from exercise of stock options and restricted stock awards, net | 6,577 | 289 | 2 |
Proceeds from Employee Stock Purchase Plan | 841 | 672 | 565 |
Net cash provided by financing activities | 55,776 | 109,499 | 154,351 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (1,431) | 1,494 | (184) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 404,098 | (7,790) | (9,867) |
Cash, cash equivalents and restricted cash at beginning of year | 32,310 | 40,100 | 49,967 |
Cash, cash equivalents and restricted cash at end of year | 436,408 | 32,310 | 40,100 |
Supplemental disclosure of cash flow information | |||
Cash paid during the year for income taxes | 1,312 | ||
Cash paid during the year for interest | 9,815 | 16,541 | 12,147 |
Non-cash investing and financing activities: | |||
Purchases of property and equipment, not yet paid | 591 | 361 | 2,698 |
Proceeds allocated to warrant liability at issuance | 7,360 | ||
Right-of-use assets obtained in exchange for operating lease liabilities | $ 2,468 | $ 40,626 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Dynavax Technologies Corporation (“we,” “our,” “us,” “Dynavax” or the “Company”), is a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines. Our first marketed product, HEPLISAV-B® (Hepatitis B Vaccine (Recombinant), Adjuvanted) is approved in the United States and European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. We also manufacture and sell CpG 1018®, the adjuvant used in HEPLISAV-B. We are working to develop CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, plague, Tdap, seasonal influenza, universal influenza and shingles. We reincorporated in Delaware in 2000. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and include our accounts and those of our wholly-owned subsidiaries, Dynavax GmbH located in Düsseldorf, Germany and Dynavax India LLP in India. All significant intercompany accounts and transactions among the entities have been eliminated from the consolidated financial statements. We operate in one business segment: discovery, development and commercialization of innovative vaccines. Liquidity and Financial Condition As of December 31, 2021, we had cash, cash equivalents and marketable securities of $ 546.0 million. In May 2021, we issued $ 225.5 million in 2.50 % convertible senior notes due 2026 (“Convertible Notes”). We used approximately $ 190.2 million of the net proceeds to retire our previous loan agreement with CRG Servicing LLC ("Loan Agreement") (see Note 11) and $ 27.2 million of the net proceeds to pay the costs of the capped call transactions (the “Capped Calls”) (see Note 10). As of December 31, 2021, the aggregate principal amount of our Convertible Notes was $ 225.5 million, excluding debt discount of $ 5.0 million (see Note 10). The Convertible Notes mature on May 15, 2026 , unless converted, redeemed or repurchased in accordance with their terms prior to such date. Prior to January 1, 2021, we incurred net losses in each year since our inception. For the year ended December 31, 2021, we recorded net income of $ 76.7 million. We cannot be certain that sales of our products, and the revenue from our other activities are sustainable. Further, we expect to continue to incur substantial expenses as we continue to invest in commercialization of HEPLISAV-B, development and procurement of our CpG 1018 adjuvant, and clinical trials and other development. If we cannot generate a sufficient amount of revenue from product sales, we will need to finance our operations through strategic alliance and licensing arrangements and/or future public or private debt and equity financings. Adequate financing may not be available to us on acceptable terms, or at all. We currently anticipate that our cash, cash equivalents and short-term marketable securities as of December 31, 2021, and anticipated revenues from HEPLISAV-B and CpG 1018 will be sufficient to fund our operations for at least the next 12 months from the date of this filing. Our ability to raise additional capital in the equity and debt markets, should we choose to do so, is dependent on a number of factors, including, but not limited to, the market demand for our common stock, which itself is subject to a number of development and business risks and uncertainties, our creditworthiness and the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us. In addition, our ability to raise additional funds may be adversely impacted by deteriorating global economic conditions and the recent or future disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic or otherwise. Raising additional funds through the issuance of equity or debt securities could result in dilution to our existing stockholders, increased fixed payment obligations, or both. In addition, these securities may have rights senior to those of our common stock and could include covenants that would restrict our operations. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management’s estimates are based on historical information available as of the date of the consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. Actual results could differ materially from these estimates. Foreign Currency Translation We consider the local currency to be the functional currency for our international subsidiaries, Dynavax GmbH and Dynavax India LLP. Accordingly, assets and liabilities denominated in this foreign currency are translated into U.S. dollars using the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at average exchange rates prevailing during the year. Currency translation adjustments arising from period to period are charged or credited to accumulated other comprehensive income (loss) in stockholders’ equity. As of December 31, 2021 and 2020, the cumulative translation adjustments balance was $( 2.3 ) million and $ 0.2 million, respectively, primarily related to the translation of Dynavax GmbH assets, liabilities and operating results from Euros to U.S. dollars. For the years ended December 31, 2021, 2020 and 2019, we reported an unrealized (loss) gain of $( 2.5 ) million, $ 2.7 million and $( 0.5 ) million, respectively. Realized gains and losses resulting from currency transactions are included in other income (expense) in the consolidated statements of operations. For the years ended December 31, 2021, 2020 and 2019, we reported a gain (loss) of $ 0.9 million, $( 0.8 ) million and $ 0.2 million, respectively, resulting from currency transactions in our consolidated statements of operations. Cash, Cash Equivalents and Marketable Securities We consider all liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. Management determines the appropriate classification of marketable securities at the time of purchase. In accordance with our investment policy, we invest in short-term money market funds, U.S. treasuries, U.S. government agency securities and corporate debt securities. We believe these types of investments are subject to minimal credit and market risk. We have classified our entire investment portfolio as available-for-sale and available for use in current operations and accordingly have classified all investments as short-term. Available-for-sale securities are carried at fair value based on inputs that are observable, either directly or indirectly, such as quoted market prices for similar securities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the securities, with unrealized gains and losses included in accumulated other comprehensive loss i n stockholders’ equity. Realized gains and losses and declines in value, if any, judged to be other than temporary on available-for-sale securities are included in interest income or expense. The cost of securities sold is based on the specific identification method. Management assesses whether declines in the fair value of investment securities are other than temporary. In determining whether a decline is other than temporary, management considers the following factors: • whether the investment has been in a continuous realized loss position for over 12 months; • the duration to maturity of our investments; • our intention and ability to hold the investment to maturity and if it is not more likely than not that we will be required to sell the investment before recovery of the amortized cost bases; • the credit rating, financial condition and near-term prospects of the issuer; and • the type of investments made. To date, there have been no declines in fair value that have been identified as other than temporary. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents, marketable securities and accounts receivable. Our policy is to invest cash in institutional money market funds and marketable securities of the U.S. government and corporate issuers with high credit quality to limit the amount of credit exposure. We currently maintain a portfolio of cash equivalents and marketable securities in a variety of securities, including short-term money market funds, U.S. treasuries, U.S. government agency securities and corporate debt securities. We have not experienced any losses on our cash equivalents and marketable securities. Our accounts receivable balance consists, primarily, of amounts due from product sales. Accounts receivable are recorded net of reserves for chargebacks, distribution fees, trade discounts and doubtful accounts. We estimate our allowance for doubtful accounts based on an evaluation of the aging of our receivables. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. To date, we have not recorded any allowance for doubtful accounts. As of December 31, 2021 and 2020, three customers collectively represented approximately 76 % and 86 % of our HEPLISAV-B trade receivable balance, respectively. As of December 31, 2021 and 2020, one customer represented approximately 94 % and 100 % of our CpG 1018 trade receivable balance, respectively. Our product candidates will require approval from the United States Food and Drug Administration ("FDA") and foreign regulatory agencies before commercial sales can commence. There can be no assurance that our products will receive any of these required approvals. The denial or delay of such approvals may have a material adverse impact on our business and may impact our business in the future. In addition, after the approval of HEPLISAV-B by the FDA, there is still an ongoing risk of adverse events that did not appear during the drug approval process. We are subject to risks common to companies in the biopharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of product candidates, product liability, the volatility of our stock price and the need to obtain additional financing. As of December 31, 2021 and 2020, 43 % and 57 %, respectively, of our long-lived assets were located in the United States and the remaining long-lived assets were located in Germany. Inventories, net HEPLISAV-B Inventories, net Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain an d if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. Additionally, for the year ended December 31, 2021, due to the COVID-19 pandemic and its prolonged impact on vaccine utilization and corresponding revisions to our sales forecast, we recorded an approximately $2.6 million write-off to cost of sales – product associated with HEPLISAV-B slow moving short-dated inventory that had been manufactured prior to the beginning of the COVID-19 pandemic. For the year ended December 31, 2020 and 2019, there were no inventory write-offs recognized. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to the required regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. HEPLISAV-B was approved by the United States Food and Drug Administration (“FDA”) on November 9, 2017, at which time we began to capitalize inventory costs associated with the vial presentation of HEPLISAV-B. In March 2018, we received regulatory approval of the pre-filled syringe (“PFS”) presentation of HEPLISAV-B. Prior to FDA approval of HEPLISAV-B, all costs related to the manufacturing of HEPLISAV-B that could potentially be available to support the commercial launch of our products, were charged to research and development expense in the period incurred as there was no alternative future use. Prior to regulatory approval of PFS, costs associated with resuming operating activities at the Düsseldorf manufacturing facility were also included in research and development expense. Subsequent to regulatory approval of PFS, costs associated with resuming manufacturing activities at the Düsseldorf facility were included in cost of sales – product, until commercial production resumed in mid-2018 at which time these costs were recorded as raw materials inventory. CpG 1018 Inventories, net Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the year ended December 31, 2021 and 2020, there were no inventory reserves recognized. Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. We evaluate the carrying value of long-lived assets, whenever events or changes in business circumstances or our planned use of long-lived assets indicate, based on undiscounted future operating cash flows, that their carrying amounts may not be fully recoverable or that their useful lives are no longer appropriate. When an indicator of impairment exists, undiscounted future operating cash flows of long-lived assets are compared to their respective carrying value. If the carrying value is greater than the undiscounted future operating cash flows of long-lived assets, the long-lived assets are written down to their respective fair values and an impairment loss is recorded. Fair value is determined primarily using the discounted cash flows expected to be generated from the use of assets. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected cash flows. In the third quarter of 2019, we recorded accelerated depreciation of $ 3.0 million related to certain long-lived assets in connection with our restructuring. See Note 17. There was no accelerated depreciation recorded during the year ended December 31, 2021 and 2020. Leases We determine if an arrangement includes a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities and long-term portion of lease liabilities in our consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, we use our incremental borrowing rate which represents an estimated rate of interest that we would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude any lease incentives. Our leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that we will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. We have elected not to apply the recognition requirements of ASC 842 for short-term leases. We have also elected the practical expedient to not separate lease components from non-lease components. As lessors, we determine if an arrangement includes a lease at inception. We elected the practical expedient to not separate lease components from non-lease components. Sublease income is recognized on a straight-line basis over the expected lease term and is included in other income (expense) in our consolidated statements of operations. Goodwill Our goodwill balance relates to our April 2006 acquisition of Dynavax GmbH. Goodwill represents the excess purchase price over the fair value of tangible and intangible assets acquired and liabilities assumed. Goodwill is not amortized but is subject to an annual impairment test. In performing its goodwill impairment review, we assess qualitative factors to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill. The qualitative factors include, but are not limited to macroeconomic conditions, industry and market considerations, and the overall financial performance of the Company. If after assessing the totality of these qualitative factors, we determine that it is not more likely than not that the fair value of its reporting unit is less than its carrying amount, then no additional assessment is deemed necessary. Otherwise, we will proceed to perform a test for goodwill impairment. The first step involves comparing the estimated fair value of the related reporting unit against its carrying amount including goodwill. If the carrying amount exceeds the fair value, the amount by which the carrying amount exceeds the reporting unit’s fair value is recorded as a charge in the consolidated statements of operations. We determined that we have only one operating segment and there are no components of that operating segment that are deemed to be separate reporting units such that we have one reporting unit for purposes of our goodwill impairment testing. We evaluate goodwill for impairment on an annual basis and on an interim basis if events or changes in circumstances between annual impairment tests indicate that the asset might be impaired. No impairment has been identified for the years presented. Convertible Notes We accounted for the Convertible Notes (see Note 10) as a long-term liability equal to the proceeds received from issuance, including the embedded conversion feature, net of the unamortized debt issuance and offering costs on the consolidated balance sheets. We evaluate all conversion, repurchase and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative. The conversion feature is not required to be accounted for separately as an embedded derivative. We amortize debt issuance and offering costs over the contractual term of the Convertible Notes, using the effective interest method, as interest expense on the consolidated statements of operations. Capped Calls We evaluate financial instruments under ASC 815. In May 2021, in connection with the issuance of the Convertible Notes, we entered into the Capped Calls (see Note 10). The Capped Calls cover the same number of shares of common stock that initially underlie the Convertible Notes (subject to anti-dilution and certain other adjustments). The Capped Calls meet the definition of derivative under ASC 815. In addition, the Capped Calls meet the conditions in ASC 815 to be classified in stockholders’ equity and are not subsequently remeasured as long as the conditions for the equity classification continue to be met. Revenue Recognition We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of Accounting Standards Codification (“ASC”) 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net – HEPLISAV-B We sell HEPLISAV-B to a limited number of wholesalers and specialty distributors in the U.S. (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one-year , there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates and other fees that are offered within contracts between us and our Customers, healthcare providers, pharmacies and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. We evaluate our estimates of variable considerations including, but not limited to, product returns, chargebacks and rebates, periodically or when there is an event or change in circumstances that may indicate that our estimates may change. Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product that has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory and other relevant factors. There were no material adjustments to these estimates for the years ended December 31, 2021 and 2019. During the fourth quarter of 2020, based on an analysis of historical product returns and customer ordering patterns, we decreased our returns reserve resulting in an increase in HEPLISAV-B product revenue, net of approximately $ 0.8 million. Chargebacks: Our Customers subsequently resell our product to healthcare providers, pharmacies and others. In addition to distribution agreements with Customers, we enter into arrangements with qualified healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare providers by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to the qualified healthcare providers, and chargebacks for units that our Customers have sold to the qualified healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances: We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees: Distribution fees include fees paid to certain Customers for sales order management, data and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Rebates: Under certain contracts, customers may obtain rebates for purchasing minimum volumes of our product. We estimate these rebates based upon the expected purchases and the contractual rebate rate and record this estimate as a reduction in revenue in the period the related revenue is recognized. Product Revenue, Net – CpG 1018 We also sell our novel adjuvant, CpG 1018, to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccine. We have determined that our collaboration partners meet the definition of customers under ASC 606. Therefore, we accounted for our CpG 1018 sales under ASC 606. Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product to the customer. Because the timing between the recognition of revenue for product sales and the receipt of payment is less than one year, there is no significant financing component on the related receivables. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Other Revenue Other revenue includes grant, collaboration and manufacturing service revenue. We have entered into grant agreements, collaborative arrangements and arrangements to provide manufacturing services to other companies. Such arrangements may include promises to customers which, if capable of being distinct, are accounted for as separate performance obligations. For agreements with multiple performance obligations, we allocate estimated revenue to each performance obligation at contract inception based on the estimated transaction price of each performance obligation. Revenue allocated to each performance obligation is then recognized when we satisfy the performance obligation by transferring control of the promised good or service to the customer. Research and Development Expenses and Accruals Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. We contract with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to our vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. Our accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. We may terminate these contracts upon written notice and we are generally only liable for actual effort expended by the organizations to the date of termination, although in certain i |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements We measure fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: • Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities; • Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities; therefore, requiring an entity to develop its own valuation techniques and assumptions. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. There were no transfers between Level 1, 2 and 3 during the years ended December 31, 2021 and 2020. The carrying amounts of cash equivalents, accounts and other receivables, accounts payable and accrued liabilities are considered reasonable estimates of their respective fair value because of their short-term nature. Recurring Fair Value Measurements The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) and liabilities measured at fair value on a recurring basis (in thousands): Level 1 Level 2 Level 3 Total December 31, 2021 Assets Money market funds $ 429,194 $ - $ - $ 429,194 U.S. treasuries - 4,004 - 4,004 U.S. government agency securities - 26,548 - 26,548 Corporate debt securities - 79,209 - 79,209 Total assets $ 429,194 $ 109,761 $ - $ 538,955 Liabilities Warrant liability $ - $ - $ 18,016 $ 18,016 Level 1 Level 2 Level 3 Total December 31, 2020 Assets Money market funds $ 23,128 $ - $ - $ 23,128 U.S. treasuries - 32,579 - 32,579 U.S. government agency securities - 40,321 - 40,321 Corporate debt securities - 61,063 - 61,063 Total assets $ 23,128 $ 133,963 $ - $ 157,091 Liabilities Warrant liability $ - $ - $ 10,736 $ 10,736 Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. U.S. treasuries, U.S. government agency securities and corporate debt securities are measured at fair value using Level 2 inputs. We review trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. Warrants were issued in connection with the underwritten public offering in August 2019 and are accounted for as a derivative liability at fair value. See Note 14. The fair value of the warrant liability is estimated using the Black-Scholes model which requires assumptions such as expected term, expected volatility and risk-free interest rate. These assumptions are subjective and require judgement to develop. Expected term is estimated using the full remaining contractual term of the warrants. We determine expected volatility based on our historical common stock price volatility. The warrant liability is classified as a Level 3 instrument as its value is based on unobservable inputs that are supported by little or no market activity. As of December 31, 2021, we used the following key assumptions to estimate the fair value of warrant liability: Number of shares 1,882,600 Expected term 0.1 years Expected volatility 0.7 Risk-free interest rate 0.1 % Dividend yield 0 % The following table provides a summary of changes in the fair value warrant liability for year ended December 31, 2021 and 2020 (in thousands): Balance at December 31, 2019 $ 14,860 Decrease in estimated fair value of warrant liability upon revaluation ( 4,124 ) Balance at December 31, 2020 $ 10,736 Decrease in fair value of warrants exercised ( 4,765 ) Warrants exercised ( 42,074 ) Increase in the estimated fair value of warrant liability upon revaluation 54,119 Balance at December 31, 2021 $ 18,016 |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 4. Cash, Cash Equivalents, Restricted Cash and Marketable Securities The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31 2021 2020 2019 Cash and cash equivalents $ 436,189 $ 32,073 $ 39,884 Restricted cash 219 237 216 Total cash, cash equivalents and restricted cash shown in the $ 436,408 $ 32,310 $ 40,100 Restricted cash balances relate to certificates of deposit issued as collateral to certain letters of credit issued as security to our lease arrangements. See Note 8. Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Unrealized Unrealized Estimated December 31, 2021 Cash and cash equivalents: Cash $ 6,995 $ - $ - $ 6,995 Money market funds 429,194 - - 429,194 Total cash and cash equivalents 436,189 - - 436,189 Marketable securities available-for-sale: U.S. treasuries 4,005 - ( 1 ) 4,004 U.S. government agency securities 26,555 - ( 7 ) 26,548 Corporate debt securities 79,200 9 - 79,209 Total marketable securities available-for-sale 109,760 9 ( 8 ) 109,761 Total cash, cash equivalents and marketable securities $ 545,949 $ 9 $ ( 8 ) $ 545,950 December 31, 2020 Cash and cash equivalents: Cash $ 7,945 $ - $ - $ 7,945 Money market funds 23,128 - - 23,128 Corporate debt securities 1,000 - - 1,000 Total cash and cash equivalents 32,073 - - 32,073 Marketable securities available-for-sale: U.S. treasuries 32,548 31 - 32,579 U.S. government agency securities 40,313 14 ( 6 ) 40,321 Corporate debt securities 60,071 3 ( 11 ) 60,063 Total marketable securities available-for-sale 132,932 48 ( 17 ) 132,963 Total cash, cash equivalents and marketable securities $ 165,005 $ 48 $ ( 17 ) $ 165,036 The maturities of our marketable securities available-for-sale are as follows (in thousands): . December 31, 2021 Amortized Estimated Mature in one year or less $ 109,760 $ 109,761 Mature after one year through two years - - $ 109,760 $ 109,761 There were no gross realized gains or losses on investments for each of the year ended December 31, 2021 and 2019. For the year ended December 31, 2020, there were gross realized gains on investments of $ 0.1 million and no gross realized losses. Realized gains are included in interest income in the consolidated statements of operations. All investments with unrealized losses at December 31, 2021 have been in a loss position for less than twelve months. We do not intend to sell the investments that are in an unrealized loss position before recovery of their amortized cost basis. To date, there have been no declines in fair value that have been identified as other than temporary. |
Inventories, Net
Inventories, Net | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories, net | 5. Inventories, net The following table presents inventories, net (in thousands): December 31 2021 2020 Raw materials $ 26,637 $ 25,121 Work-in-process 14,748 30,293 Finished goods 19,950 8,275 Total $ 61,335 $ 63,689 As of December 31, 2021 and 2020, included in finished goods inventory was $ 18.6 million and $ 8.3 million of HEPLISAV-B inventory, respectively. The remaining balance in finished goods inventory was CpG 1018 adjuvant. There was no CpG 1018 adjuvant within raw materials and work-in-process inventory balance as of December 31, 2021 and 2020. Additionally, for the year ended December 31, 2021, due to the COVID-19 pandemic and its prolonged impact on vaccine utilization and corresponding revisions to our sales forecast, we recorded an approximately $ 2.6 million write-off to cost of sales – product associated with HEPLISAV-B slow moving short-dated inventory that had been manufactured prior to the beginning of the COVID-19 pandemic. For the year ended December 31, 2020 and 2019, there were no inventory write-offs recognized. We recorded prepaid manufacturing costs related to prepayments made to third-party manufacturers of CpG 1018 adjuvant, of $ 159.7 million and $ 29.4 million as of December 31, 2021 and 2020, respectively. We expect these costs to be converted into inventory within the next twelve months. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, net Property and equipment consist of the following (in thousands): Estimated Useful December 31, Life 2021 2020 Manufacturing equipment 5 - 13 $ 12,532 $ 13,884 Lab equipment 5 - 13 2,492 2,888 Computer equipment 3 5,336 5,255 Furniture and fixtures 3 - 13 2,463 2,510 Leasehold improvements 2 - 10 27,634 28,417 Assets in progress 9,941 1,024 60,398 53,978 Less accumulated depreciation and amortization ( 25,378 ) ( 23,411 ) Total $ 35,020 $ 30,567 Depreciation and amortization expense on property and equipment was $ 4.3 million, $ 4.3 million and $ 8.9 million for the years ended December 31, 2021, 2020 and 2019, respectively. Included in depreciation and amortization expense for the year ended December 31, 2019 was accelerated depreciation of $ 3.0 million related to certain long-lived assets. See Note 17. |
Current Accrued Liabilities and
Current Accrued Liabilities and Accrued Research and Development | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Component Of Current Accrued Liabilities And Accrued Research And Development [Abstract] | |
Current Accrued Liabilities and Accrued Research and Development | 7. Current Accrued Liabilities and Accrued Research and Development Current accrued liabilities consist of the following (in thousands): December 31, 2021 2020 Payroll and related expenses $ 13,011 $ 8,684 Revenue reserve accruals 8,253 6,040 Accrued inventory 20,868 338 Other accrued liabilities 7,664 4,037 Total $ 49,796 $ 19,099 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Leases We lease our facilities in Emeryville, California and Düsseldorf, Germany. In July 2019, we entered into a sublease for office space located at 2100 Powell Street, Emeryville, California (the “Powell Street Sublease”). Under the terms of the Powell Street Sublease, we are leasing 23,976 square feet at the rate of $ 3.90 per square foot, paid on a monthly basis. Rent is subject to scheduled annual increases and we are responsible for certain operating expenses and taxes throughout the life of the Powell Street Sublease. The Powell Street Sublease will continue until June 30, 2022 . There is no option to extend the sublease term. In September 2018, we entered into a lease (“Horton Street Master Lease”) for office and laboratory space located at 5959 Horton Street, Emeryville, California (“Horton Street Premises”). Under the terms of the Horton Street Master Lease, we are leasing 75,662 square feet at the rate of $ 4.75 per square foot, paid on a monthly basis, starting on April 1, 2019 (“Commencement Date”). Rent is subject to scheduled annual increases, and we are also responsible for certain operating expenses and taxes throughout the life of Horton Street Master Lease. In connection with the Horton Street Master Lease, we have received tenant improvement allowance totaling $ 8.1 million through December 31, 2021. The Horton Street Master Lease has an initial term of 12 years, following the Commencement Date with an option to extend the lease for two successive five-year terms . The optional periods were not included in the lease term used in determining the right-of-use asset or the lease liability as we did not consider it reasonably certain that we would exercise the options. The operating lease right-of-use assets and liabilities on our December 31, 2021 and 2020 consolidated balance sheets primarily relate to the Horton Street Master Lease. Lease expense related to the Horton Street Master Lease is included in operating expense in our consolidated statements of operations. In connection with the organizational restructuring in May 2019, we did not occupy the Horton Street Premises and in July 2019, we entered into an agreement to sublease the Horton Street Premises to a third party (“Horton Street Sublease”). Under the terms of the Horton Street Sublease, we are subleasing the entire 75,662 rentable square feet at the rate of $ 5.50 per square foot, paid on a monthly basis. Rent is subject to scheduled annual increases and the subtenant (“Subtenant”) is responsible for certain operating expenses and taxes throughout the life of the Horton Street Sublease. The Horton Street Sublease term is until March 31, 2031 , unless earlier terminated, concurrent with the term of our Horton Street Master Lease. The Subtenant has no option to extend the sublease term. For the years ended December 31, 2021, 2020 and 2019, we recognized $ 7.7 million, $ 7.7 million and $ 2.6 million, respectively of sublease income included in other income (expense) in our consolidated statements of operations. Under the terms of the Horton Street Master Lease, rent received from the Subtenant in excess of rent paid to the landlord is shared by paying the landlord 50 % of the excess rent. The excess rent is considered a variable lease payment and the total estimated payments are being recognized as additional rent expense on a straight-line basis. In September 2021, we entered into a commercial lease agreement in Düsseldorf, Germany (the "New Düsseldorf Lease"). The New Düsseldorf Lease is for the same space that we currently lease in Düsseldorf, Germany and with the same landlord. Our existing lease will continue until December 31, 2021, at which point the New Düsseldorf Lease will be in effect. We have determined that the New Düsseldorf Lease qualifies as a modification not accounted for as a separate contract. The New Düsseldorf Lease has an initial term of 10 years, beginning on January 1, 2022 , with an option to extend the lease for two successive five-year terms. The optional periods were not included in the lease term used in determining the right-of-use assets and liabilities as we did not consider it reasonably certain that we would exercise the options. Beginning on January 1, 2024, the base rent is subject to an annual increase at the same percentage of Consumer Price Index of Germany. We are also responsible for certain operating expenses and taxes throughout the life of the New Düsseldorf Lease. We used our estimated incremental borrowing rate of 10.1 % to recognize the initial right-of-use asset for the New Düsseldorf Lease. Our lease expense comprises of the following (in thousands): Year Ended December 31, 2021 2020 2019 Operating lease expense $ 6,265 $ 6,267 $ 6,886 Cash paid for amounts included in the measurement of lease liabilities for the years ended December 31, 2021 and 2020 was $ 7.0 million and $ 6.9 million, respectively and were included in change in lease liabilities in our consolidated statement of cash flows. The balance sheet classification of our operating lease liabilities was as follows (in thousands): December 31, 2021 December 31, 2020 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 2,577 $ 3,247 Long-term portion of lease liabilities 34,316 34,789 Total operating lease liabilities $ 36,893 $ 38,036 At December 31, 2021, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease 2022 $ 5,357 $ 6,174 2023 5,518 5,634 2024 5,684 5,778 2025 5,854 5,927 2026 6,030 6,080 Thereafter 27,712 28,259 Total $ 56,155 57,852 Less: Present value adjustment ( 20,959 ) Total $ 36,893 The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liability were as follows: December 31, 2021 December 31, 2020 Weighted average remaining lease term 9.1 years 9.1 years Weighted average discount rate 10.1 % 10.1 % Commitments As of December 31, 2021, our purchase commitments include non-cancelable purchase for the supply of HEPLISAV-B and CpG 1018 adjuvant. The following summarizes our material purchase commitments at December 31, 2021 and the effect those obligations are expected to have on our liquidity and cash flows in future periods (in thousands): Years ending December 31, (in thousands) 2022 $ 55,318 2023 9,312 2024 10,857 2025 11,367 2026 11,872 Thereafter - Total 98,726 In addition to the non-cancelable commitments included above, we have entered into contractual arrangements that obligate us to make payments to the contractual counterparties upon the occurrence of future events. In addition, in the normal course of operations, we have entered into license and other agreements and intend to continue to seek additional rights relating to compounds or technologies in connection with our discovery, manufacturing and development programs. Under the terms of the agreements, we may be required to pay future up-front fees, milestones and royalties on net sales of products originating from the licensed technologies, if any, or other payments contingent upon the occurrence of future events that cannot reasonably be estimated. We also rely on and have entered into agreements with research institutions, contract research organizations and clinical investigators as well as clinical material manufacturers. These agreements are terminable by us upon written notice. Generally, we are liable only for actual effort expended by the organizations at any point in time during the contract through the notice period. As of December 31, 2021, the aggregate principal amount of our Convertible Notes was $ 225.5 million, excluding debt discount of $ 5.0 million (see Note 10). The Convertible Notes mature on May 15, 2026 , unless converted, redeemed or repurchased in accordance with their terms prior to such date. During 2004, we established a letter of credit with Deutsche Bank as security for our Düsseldorf Lease in the amount of € 0.2 million (Euros). The letter of credit remained outstanding through December 31, 2021 and is collateralized by a certificate of deposit for € 0.2 million, which has been included in restricted cash in the consolidated balance sheets as of December 31, 2021 and 2020. Sale of SD-101 Program In July 2020, we sold assets related to our immuno-oncology compound, SD-101, which included intellectual property, clinical and non-clinical data, regulatory filings, clinical supply inventory and certain contracts, to Surefire Medical Inc. d/b/a TriSalus Life Sciences (“TriSalus”). Pursuant to the Asset Purchase Agreement, we received $ 5 million upon closing of the transaction and $ 4 million in December 2020 as reimbursement for certain clinical trial expenses. In addition, we could receive up to an additional $ 250 million upon the achievement of certain development, regulatory, and commercial milestones and low double-digit royalties based on potential future net sales of product containing SD-101 compound. In September 2021, we received payment of $ 1 million from TriSalus for their meeting a pre-commercialization milestone. For the year ended December 31, 2021 and 2020, we recognized a gain on sale of SD-101 assets of $ 1 million and $ 6.9 million, respectively based on the amount of consideration received, net of any transaction costs. In conjunction with our agreement with Symphony Dynamo, Inc. and Symphony Dynamo Holdings LLC (“Holdings”) in November 2009, we agreed to make contingent cash payments to Holdings equal to 50 % of the first $ 50 million from any upfront, pre-commercialization milestone or similar payments received by us from any agreement with any third party with respect to the development and/or commercialization of cancer and hepatitis C therapies originally licensed to Symphony Dynamo, Inc., including SD-101. Pursuant to this agreement, we paid Holdings $ 0.5 million in September 2021 and $ 2.5 million in August 2020 which were included in selling, general and administrative expense in our consolidated statements of operations for the year ended December 31, 2021 and 2020, respectively. Contingencies From time to time, we may be involved in claims, suits, and proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, commercial claims, and other matters. Such claims, suits, and proceedings are inherently uncertain and their results cannot be predicted with certainty. Regardless of the outcome, such legal proceedings can have an adverse impact on us because of legal costs, diversion of management resources, and other factors. In addition, it is possible that a resolution of one or more such proceedings could result in substantial damages, fines, penalties or orders requiring a change in our business practices, which could in the future materially and adversely affect our financial position, financial statements, results of operations, or cash flows in a particular period. |
Collaborative Research, Develop
Collaborative Research, Development and License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Research and Development [Abstract] | |
Collaborative Research, Development and License Agreements | 9. Collaborative Research, Development and License Agreements Coalition for Epidemic Preparedness Innovations In September 2020, we entered into a Reservation Agreement for the Provision of Goods (the “Reservation Agreement”) with Coalition for Epidemic Preparedness Innovations (“CEPI”) to make available specified quantities of CpG 1018 adjuvant, for purchases at certain prices, to CEPI and its COVID-19 vaccine development partners. Payments received under the Reservation Agreement are considered an exchange for our CpG 1018 adjuvant which is an output of our ordinary activities. As such, we account for the arrangement under the scope of ASC 606. Payments are recorded as deferred revenue and recognized as revenue in the period when we satisfy our performance obligation to deliver CpG 1018 ordered or when CEPI’s right to place an order expires. Pursuant to the Reservation Agreement, we received $ 6.3 million from CEPI in September 2020 for production scale-up and a fourth quarter 2020 reservation fee. In October 2020, CEPI terminated the Reservation Agreement and its right to place an order expired. Therefore, we recognized $ 6.3 million as other revenue in the fourth quarter of 2020. In January 2021, we entered into an agreement (the “CEPI Agreement”) with CEPI for the manufacture and reservation of a specified quantity of CpG 1018 adjuvant (“CpG 1018 Materials”). The CEPI Agreement enables CEPI to direct the supply of CpG 1018 Materials to CEPI partners. CEPI partner(s) would purchase CpG 1018 Materials under separately negotiated agreements. The CEPI Agreement also allows us to sell CpG 1018 Materials to third parties if not purchased by a CEPI partner within a two-year term. In exchange for reserving CpG 1018 Materials and agreeing to sell CpG 1018 Materials to CEPI partner(s) at pre-negotiated prices, CEPI agreed to provide payments in the form of an interest-free, unsecured, forgivable loan (the “Advance Payments”) of up to $ 99.0 million. We are obligated to repay the Advance Payments, in proportion to quantity sold, if and to the extent we receive payments from sales of CpG 1018 Materials reserved under the CEPI Agreement. If the vaccine programs pursued by CEPI partner(s) are unsuccessful and no alternative use is found for CpG 1018 Materials reserved under the CEPI Agreement, the applicable Advance Payments will be forgiven at the end of the two-year term. In May 2021, we entered into the first Amendment to the CEPI Agreement. This Amendment provided for the manufacture and reservation of an additional specified quantity of CpG 1018 adjuvant. In exchange for reserving an additional specified quantity of CpG 1018 adjuvant, CEPI agreed to provide additional Advance Payments of up to $ 77.4 million, together with the initial CEPI Agreement, for total Advance Payments of up to $ 176.4 million. We determined that the accounting of the Advance Payments is under the scope of ASC 606. The Advance Payments are to cover the costs of manufacture and to reserve CpG 1018 Materials, which is an output of our ordinary activities. As such, the Advance Payments are initially classified as long-term deferred revenue in our consolidated balance sheets. We are obligated to repay CEPI, in proportion to quantity sold and within a certain period, upon receipt of payment from CEPI partner(s). Thus, when we deliver CpG 1018 Materials to CEPI partner(s) or when we receive payment from CEPI partner(s), we reclassify the Advanced Payments from long-term deferred revenue to accrued liabilities. We recognize the Advance Payments as revenue when the amount (or a portion thereof) is forgiven by CEPI when (i) the CpG 1018 Materials are not sold through to CEPI partner(s), (ii) there is no alternative use and (iii) the CpG 1018 Materials are destroyed. Through December 31, 2021, we have received Advance Payments totaling approximately $ 168.5 million pursuant to the CEPI Agreement. As of December 31, 2021, advance payments totaling $ 5.4 million were included in other long-term liabilities and $ 128.8 million were recorded as CEPI accrual in our consolidated balance sheets. As of December 31, 2021, we recorded $ 14.6 million in CEPI receivable which is included in other receivables in our consolidated balance sheets. There were no such balances recorded in our consolidated balance sheets as of December 31, 2020. Zhejiang Clover Biopharmaceuticals, Inc. and Clover Hong Kong Inc. In June 2021, we entered into an agreement with Zhejiang Clover Biopharmaceuticals, Inc. and Clover Hong Kong Inc. (collectively, “Clover”), for the commercial supply of CpG 1018 adjuvant, for use with Clover’s COVID-19 vaccine candidate, SCB-2019 (the “Clover Supply Agreement”). Under the Clover Supply Agreement, Clover has committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Clover’s commercialization of vaccines containing SCB-2019 and CpG 1018 adjuvant (“Clover Product”). The Clover Supply Agreement also provides terms for Clover to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. Pricing for CpG 1018 adjuvant is variable depending on the destination where Clover ultimately sells Clover Product to. Pursuant to the Clover Supply Agreement, our initial invoicing is at the lowest price tier, with a true-up mechanism to issue additional invoice for the difference between the initial invoice price and the higher tiered price, if any. In addition, if the net selling price of such Clover Product exceeds a threshold specified in the Clover Supply Agreement, we are entitled to a royalty calculated as a percentage of the excess portion of such net selling price. For CpG 1018 adjuvant reserved for Clover under the CEPI Agreement, Clover is obligated to pay the purchase price upon the earliest of (i) the true-up exercise, (ii) within a specified period after Clover delivers Clover Product to a customer, or (iii) Clover’s receipt of payment for Clover Product from a customer. For CpG 1018 adjuvant ordered by Clover outside the CEPI Agreement, Clover is obligated to pay a specified percentage of the purchase price, as set forth in a purchase order submitted by Clover, upon our acceptance of such purchase order, and the remainder of the purchase price upon the release of such CpG 1018 adjuvant. We recognize revenue at the lowest price tier upon transfer of control of CpG 1018 adjuvant to Clover. The potential true-up amount and royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue. When we transfer control of CpG 1018 adjuvant that is reserved under the CEPI Agreement, we recognize product revenue and a corresponding contract asset as our right to consideration is contingent on something other than the passage of time, as outlined above. As of December 31, 2021, our contract asset balance of $ 62.5 million was included in other current assets in our consolidated balance sheets. As of December 31, 2021, we recorded accounts receivable balance of $ 2.1 million from Clover. As of December 31, 2021, we recognized approximately $ 191.1 million in deferred revenue for a portion of Clover’s binding commitment to purchase CpG 1018 adjuvant outside the CEPI Agreement. There was no deferred revenue recognized for a portion of Clover’s binding commitment to purchase CpG 1018 adjuvant that was reserved for Clover under the CEPI Agreement. There was no contract asset, accounts receivable or deferred revenue balance at the beginning of the period. For the year ended December 31, 2021, we recognized CpG 1018 product revenue of $ 72.2 million from Clover. There was no CpG 1018 product revenue from Clover recognized during the year ended December 31, 2020 and 2019. Biological E. Limited In July 2021, we entered into an agreement (the “Bio E Supply Agreement”) with Biological E. Limited (“Bio E”), for the commercial supply of CpG 1018 adjuvant, for use with Bio E’s subunit COVID-19 vaccine candidate, CORBEVAX. Under the Bio E Supply Agreement, Bio E has committed to purchase specified quantities of CpG 1018 adjuvant, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Bio E’s commercialization of its CORBEVAX vaccine (“Bio E Product”) with specified delivery dates in 2021 and the first quarter of 2022. The Bio E Supply Agreement also provides terms for Bio E to order additional quantities of CpG 1018 adjuvant beyond the quantities reserved by CEPI. Pricing for CpG 1018 adjuvant is variable depending on the destination where Bio E ultimately sells Bio E Product to. Pursuant to the Bio E Supply Agreement, our initial invoicing will be at the lowest price tier, with a true-up mechanism to issue additional invoice for the difference between the initial invoice price and the higher tiered price, if any. In addition, if the net selling price of such Bio E Product exceeds a threshold specified in the Bio E Supply Agreement, we are entitled to a royalty calculated as a percentage of the excess portion of such net selling price. For CpG 1018 adjuvant reserved for Bio E under the CEPI Agreement, Bio E is obligated to pay, in full, the aggregate purchase price, as set forth in a purchase order submitted by Bio E, upon delivery of CpG 1018 adjuvant. For CpG 1018 adjuvant ordered by Bio E outside the CEPI Agreement, Bio E is obligated to pay a specified percentage of the purchase price, as set forth in a purchase order submitted by Bio E, upon our acceptance of such purchase order, and the remainder of the purchase price upon the delivery of such CpG 1018 adjuvant. We recognize revenue at the lowest price tier upon transfer of control of CpG 1018 adjuvant to Bio E. The potential true-up amount and royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue. As of December 31, 2021, we recorded accounts receivable balance of $ 96.1 million from Bio E. As of December 31, 2021, we recognized approximately $ 103.3 million in deferred revenue for a portion of Bio E’s binding commitment to purchase CpG 1018 adjuvant outside the CEPI Agreement. There was no deferred revenue recognized for a portion of Bio E’s binding commitment to purchase CpG 1018 adjuvant that was reserved for Bio E under the CEPI Agreement. There was no accounts receivable or deferred revenue balance at the beginning of the period. For the year ended December 31, 2021, we recognized CpG 1018 product revenue of $ 185.7 million from Bio E. There was no CpG 1018 product revenue from Bio E recognized during the year ended December 31, 2020 and 2019. Medigen Vaccine Biologics In February 2021, we entered into a Supply Agreement (“Medigen Supply Agreement”) with Medigen Vaccine Biologics (“Medigen”) to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the development and commercialization of Medigen’s COVID-19 vaccine for delivery in the first and second quarters of 2021. In August 2021, we entered into a second supply agreement (“Medigen Supply Agreement No. 2”) to manufacture and supply additional specified quantities of CpG 1018 adjuvant for delivery in the third and fourth quarter of 2021. Under Medigen Supply Agreement No. 2, pricing for CpG 1018 adjuvant is variable depending on the destination where Medigen ultimately sells Medigen Product to. Pursuant to the Medigen Supply Agreement No. 2, we invoice Medigen based on the highest-tier price, with a true-up mechanism to issue credit to Medigen for the difference between the initial invoice price and the lower tiered price, if any. We invoice Medigen a specified percentage of the aggregate price of the order upon acceptance of the order and the remaining upon delivery. In addition, we are entitled to a royalty calculated as a percentage of the adjusted net sales. We recognize revenue upon transfer of control of CpG 1018 adjuvant to Medigen at the highest-tiered price. The potential royalties are considered constrained. There is no significant financing component, as the timing between shipment and payment is expected to be within twelve months. Payments received or invoices issued before we transfer control of CpG 1018 adjuvant are recorded as deferred revenue. As of December 31, 2021, we recorded accounts receivable balance of $ 2.4 million from Medigen. There was no accounts receivable balance at the beginning of the period. For the year ended December 31, 2021 and 2020, we recognized CpG 1018 product revenue from Medigen of $ 26.7 million and $ 1.2 million, respectively. There was no CpG 1018 product revenue from Medigen recognized during the year ended December 31, 2019. Valneva SE In April 2020, we entered into a collaboration agreement ("Valneva Collaboration Agreement") with Valneva Scotland Limited (“Valneva”) to provide CpG 1018 adjuvant for use in the development of Valneva’s COVID-19 vaccine candidate ("VLA2001"). The Valneva Collaboration Agreement was amended in July 2020, to provide additional quantities of CpG 1018 adjuvant. In September 2020, we entered into a supply agreement (“Valneva Supply Agreement”) with Valneva to manufacture and supply specified quantities of CpG 1018 adjuvant for use in the commercialization of VLA2001. We concluded that the Valneva Collaboration Agreement and the Valneva Supply Agreement were entered into at or near the same time, with the same customer and were negotiated as a package with a single commercial objective to provide CpG 1018 adjuvant to Valneva. Therefore, the Valneva Collaboration Agreement and the Valneva Supply Agreement should be combined and accounted for as a single arrangement. In October 2021, we and Valneva entered into a letter agreement (the “Valneva Amendment”) modifying certain deliverables of the Valneva Supply Agreement. Specifically, the Valneva Amendment modifies the original Valneva Supply Agreement as follows: (1) cancels certain purchase orders for CpG 1018 adjuvant previously issued under the original Valneva Supply Agreement that had not been fulfilled as of the date of the Valneva Amendment; and (2) provides a future delivery schedule for commercial supply of CpG 1018 adjuvant through 2022. As of the date of the Valneva Amendment, we had received non-refundable advance payments of approximately $ 55.4 million associated with the cancelled purchase orders. In accordance with revenue recognition guidance in ASC 606, the Valneva Amendment was determined to be a contract modification and will be accounted for prospectively as one agreement with consideration allocated to future performance obligations. We have identified one remaining performance obligation which is the delivery of CpG 1018 adjuvant through 2022. The total amount of consideration allocated to the remaining performance obligation includes approximately $ 55.4 million of advance payments received as of the date of the Valneva Amendment plus additional future consideration to be received in connection with final delivery of product. As of December 31, 2021, approximately $ 55.4 million of advance payments remain recorded as deferred revenue and will be recognized as product revenue when we satisfy our remaining performance obligation to deliver CpG 1018 adjuvant under the Valneva Amendment. As of December 31, 2021 and 2020, deferred revenue related to Valneva was $ 55.4 million and $ 37.0 million, respectively. For the year ended December 31, 2021 and 2020, we recognized CpG 1018 product revenue of $ 89.4 million and $ 2.0 million, respectively. There was no CpG 1018 product revenue from Valneva recognized during the year ended December 31, 2019. Bill & Melinda Gates Foundation Grant Agreement In July 2020, we entered into a grant agreement (the "BMGF Grant Agreement") with Bill & Melinda Gates Foundation (“BMGF”), under which we were awarded a grant of up to $ 3.4 million to scale up production of our CpG 1018 adjuvant to support the global COVID-19 response and we received $ 1.2 million of the grant from BMGF which we accounted for as deferred revenue in our consolidated balance sheets as of December 31, 2020. In July 2021, the BMGF Grant Agreement expired. Pursuant to the BMGF Grant Agreement, we were not obligated to return the $ 1.2 million funding that we spent on grant-related activities. For the year ended December 31, 2021, we recognized $ 1.2 million as other revenue in our consolidated statements of operations. U.S. Department of Defense In September 2021, we entered into an agreement with the U.S. Department of Defense ("DoD") for the development of a recombinant plague vaccine adjuvanted with CpG 1018 for approximately $ 22.0 million over two and a half years. Under the agreement, we will conduct a Phase 2 clinical trial combining our CpG 1018 adjuvant with the DoD's rF1V vaccine. We anticipate the Phase 2 trial will commence in 2022. For the year ended December 31, 2021, we recognized revenue of $ 0.5 million which are included in other revenue in our consolidated statements of operations. Serum Institute of India Pvt. Ltd. In June 2017, we entered into an agreement to provide Serum Institute of India Pvt. Ltd. (“SIIPL”) with technical support. In consideration, SIIPL agreed to pay us at an agreed upon hourly rate for services and reimburse certain out-of-pocket expenses. In addition, we have rights to commercialization of certain potential products manufactured at the SIIPL facility. For the years ended December 31, 2021, 2020 and 2019, we recognized collaboration revenue of $ 0.4 million, $ 0.9 million and $ 0.1 million, respectively which are included in other revenue in our consolidated statements of operations. |
Convertible Notes
Convertible Notes | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Convertible Notes | 10. Convertible Notes In May 2021, we issued $ 200.0 million aggregate principal amount of 2.50 % convertible senior notes due 2026 in a private placement. The purchasers also partially exercised their option to purchase additional Convertible Notes in May 2021 and we issued an additional $ 25.5 million of the Convertible Notes. Total proceeds from the issuance of the Convertible Notes, net of debt issuance and offering costs of $ 5.7 million, were $ 219.8 million. We used $ 190.2 million of the net proceeds to repay, in full, our outstanding debt and other obligations under the Loan Agreement (see Note 11) and $ 27.2 million of the net proceeds to pay the costs of the capped call transactions described below. The Convertible Notes are general unsecured obligations and accrue interest at a rate of 2.50% per annum payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021 . The Convertible Notes mature on May 15, 2026 , unless converted, redeemed or repurchased in accordance with their terms prior to such date. The Convertible Notes are convertible into cash, shares of our common stock or a combination of cash and shares of our common stock, at our election, at an initial conversion rate of 95.5338 shares of our common stock per $ 1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $ 10.47 per share of our common stock. The Convertible Notes are convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding February 15, 2026, only under the following circumstances: 1. During any calendar quarter commencing after September 30, 2021 (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price on each applicable trading day; 2. During the five business day period after any ten consecutive trading day period (the “measurement period”), in which the “trading price” (as defined the indenture governing the Convertible Notes) per $1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; 3. If we call such Convertible Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or 4. Upon the occurrence of specified corporate events as set forth in the indenture governing the Convertible Notes. On or after February 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders of the Convertible Notes may convert all or any portion of their Convertible Notes regardless of the foregoing circumstances. The Convertible Notes were convertible, in whole or in part, at the option of the holders between October 1, 2021 through December 31, 2021 as the conditions allowing holders of the Convertible Notes to convert have been met. None of the Convertible Notes had been converted during this period. On January 1, 2022, the conditional conversion feature of the Convertible Notes was triggered as the last reported sale price of our common stock was more than or equal to 130 % of the conversion price for at least 20 trading days in the period of 30 consecutive trading days ending on December 31, 2021 (the last trading day of the immediately preceding fiscal quarter), and therefore the Convertible Notes are currently convertible, in whole or in part, at the option of the holders between January 1, 2022 through March 31, 2022. Whether the Convertible Notes will be convertible following such period will depend on the continued satisfaction of this condition or another conversion condition in the future. We had not received any conversion notices. Since we have the election of repaying the Convertible Notes in cash, shares of our common stock, or a combination of both, we continued to classify the Convertible Notes as long-term debt on the consolidated balance sheets as of December 31, 2021. We may redeem for cash all or any portion of the Convertible Notes, at our option, on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130 % of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100 % of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If we undergo a fundamental change (as set forth in the indenture governing the Convertible Notes), noteholders may require us to repurchase for cash all or any portion of their Convertible Notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to the fundamental change repurchase date. In addition, following certain corporate events (as set forth in the indenture governing the Convertible Notes) or if we deliver a notice of redemption prior to the maturity date, we will, in certain circumstances, adjust the conversion rate for a noteholder who elects to convert its notes in connection with such a corporate event or such notice of redemption. As a result of adopting ASU 2020-06, we accounted for the Convertible Notes as a single liability. As of December 31, 2021, the Convertible Notes were recorded at the aggregate principal amount of $ 225.5 million less unamortized issuance costs of $ 5.0 million as a long-term liability on the consolidated balance sheets. As of December 31, 2021, the fair value of the Convertible Notes was $ 368.6 million. See Note 2. The debt issuance costs are amortized to interest expense over the contractual term of the Convertible Notes at an effective interest rate of 3.1 %. The following table presents the components of interest expense related to Convertible Notes (in thousands): Year Ended December 31, 2021 Stated coupon interest $ 3,555 Amortization of debt issuance cost 669 Total interest expense $ 4,224 Capped Calls In connection with the issuance of the Convertible Notes, we entered into capped call transactions with one of the initial purchasers of the Convertible Notes and other financial institutions, totaling $ 27.2 million (the “Capped Calls”). The Capped Calls cover, subject to customary adjustments, the number of shares of our common stock that initially underlie the Convertible Notes (or 21,542,871 shares of our common stock). The Capped Calls have an initial strike price and an initial cap price of $ 10.47 per share and $ 15.80 per share, respectively, subject to certain adjustments. Conditions that cause adjustments to the initial strike price of the Capped Calls mirror conditions that result in corresponding adjustments to the conversion price of the Convertible Notes. The Capped Calls are expected to offset the potential dilution to our common stock as a result of any conversion of the Convertible Notes, subject to a cap based on the cap price. For accounting purposes, the Capped Calls are considered separate financial instruments and not part of the Convertible Notes. As the Capped Calls transactions meet certain accounting criteria, we recorded the cost of the Capped Calls, totaling $ 27.2 million, as a reduction to additional paid-in capital within the consolidated statements of stockholders’ equity. |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 11. Long-Term Debt Long-Term Debt On February 20, 2018, we entered into a $ 175.0 million term Loan Agreement with CRG Servicing LLC. We borrowed $ 100.0 million under the Loan Agreement at closing and the remaining $ 75.0 million in March 2019 (collectively, “Term Loans”). Net proceeds under the Loan Agreement were $ 173.3 million. The Term Loans under the Loan Agreement bore interest at a rate equal to 9.5 % per annum. The Term Loans had a maturity date of December 31, 2023 . In May 2021, we repaid the principal on the Term Loans, in full, using the net proceeds from the Convertible Notes issuance. In connection with the early repayment of the Term Loans, in the second quarter of 2021, we recorded $ 5.2 million loss on debt extinguishment related to the amount we paid to terminate the Term Loans in excess of its carrying value at the time of the repayment. Our final payment of $ 190.2 million to CRG Servicing LLC satisfied all of our obligations under the Loan Agreement. With the full repayment of the Term Loans, all security interests, covenants, liens and encumbrances under the Loan Agreement were permanently released. We recorded $ 7.0 million, $ 19.1 million and $ 16.5 million of interest expense related to the Term Loans during the year ended December 31, 2021, 2020 and 2019, respectively. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2021 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 12. Revenue Recognition Disaggregation of Revenues The following table disaggregates our product revenue, net by product and geographic region and disaggregates our other revenues by geographic region (in thousands): Year Ended Year Ended Year Ended December 31, 2021 December 31, 2020 December 31, 2019 U.S. Non U.S. Total U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 61,870 $ - $ 61,870 $ 36,030 $ - $ 36,030 $ 34,644 $ - $ 34,644 CpG 1018 - 375,229 375,229 - 3,277 3,277 - - - Total product revenue, net $ 61,870 $ 375,229 $ 437,099 $ 36,030 $ 3,277 $ 39,307 $ 34,644 $ - $ 34,644 Other revenue 1,915 428 2,343 - 7,244 7,244 410 165 575 Total revenues $ 63,785 $ 375,657 $ 439,442 $ 36,030 $ 10,521 $ 46,551 $ 35,054 $ 165 $ 35,219 Revenues from Major Customers The following table summarizes HEPLISAV-B product revenue from each of our three largest Customers (as a percentage of total HEPLISAV-B product revenue): Year Ended December 31, 2021 2020 2019 Largest Customer 21 % 21 % 22 % Second largest Customer 19 % 20 % 21 % Third largest Customer 19 % 20 % 19 % The following table summarizes CpG 1018 product revenue from each of our three largest collaboration partners (as a percentage of total CpG 1018 product revenue): Year Ended December 31, 2021 2020 2019 Largest collaboration partner 49 % 62 % 0 % Second largest collaboration partner 24 % 36 % 0 % Third largest collaboration partner 19 % 2 % 0 % Contract Balances The following table summarizes balances and activities in HEPLISAV-B product revenue allowance and reserve categories (in thousands): Balance at Provisions Credit or payments Balance Year ended December 31, 2021: Accounts receivable reserves(1) $ 2,836 $ 18,209 $ ( 17,222 ) $ 3,823 Revenue reserve accruals(2) $ 6,040 $ 13,077 $ ( 10,864 ) $ 8,253 Year ended December 31, 2020: Accounts receivable reserves(1) $ 2,701 $ 11,417 $ ( 11,282 ) $ 2,836 Revenue reserve accruals(2) $ 3,893 $ 6,694 $ ( 4,547 ) $ 6,040 (1) Reserves are for chargebacks, discounts and other fees. (2) Accruals are for returns, rebates and other fees. When we transfer control of CpG 1018 adjuvant that is reserved under the CEPI Agreement to Clover, we recognize product revenue and a corresponding contract asset as our right to consideration is conditioned on something other than the passage of time. See Note 9 for further discussion. The following table summarizes balances and activities in our contract asset account (in thousands): Balance at Additions (1) Subtractions Balance Year ended December 31, 2021: Contract asset $ - $ 62,525 $ - $ 62,525 Year ended December 31, 2020: Contract asset $ - $ - $ - $ - (1) Additions are revenues recognized for CpG 1018 adjuvant transferred to Clover that is reserved under the CEPI Agreement. Payments received or invoices issued before we satisfy our performance obligations are recorded as deferred revenue until we satisfy such performance obligations. Our deferred revenue activities are related to CpG 1018 product sales. The following table summarizes balances and activities in our deferred revenue accounts (in thousands): Balance at Additions (1) Subtractions (2) Revenue recognized in the current period included in deferred revenue balance at the beginning of the period Balance Year ended December 31, 2021: Deferred revenue $ 38,212 $ 371,860 $ ( 21,996 ) $ ( 38,212 ) $ 349,864 Long-term deferred revenue - 168,467 ( 163,082 ) - 5,385 Year ended December 31, 2020: Deferred revenue $ - $ 38,212 $ - $ - $ 38,212 Long-term deferred revenue - - - - - (1) Additions are primarily payments received or invoices issued before we satisfy our performance obligations. Subtractions are primarily revenues recognized in the period and reclassification from long-term deferred revenue to CEPI accrual. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. Net Income (Loss) Per Share We compute net income (loss) per share of common stock using the two-class method required for participating securities. We consider Series B Preferred Stocks and warrants to be participating securities because holders of such shares have dividend rights in the event of our declaration of a dividend for common shares. Undistributed earnings allocated to participating securities are subtracted from net income (loss) in determining net income (loss) attributable to common stockholders. Basic net income (loss) per share is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of shares of our common stock outstanding. For the calculation of diluted net income (loss) per share, net income (loss) attributable to common stockholders for basic net income (loss) per share is adjusted by the effect of dilutive securities, including awards under our equity compensation plans and change in fair value of warrant liability. Diluted net income (loss) per share attributable to common stockholders is computed by dividing the resulting net income (loss) attributable to common stockholders by the weighted-average number of fully diluted common shares outstanding. Year Ended December 31, 2021 2020 2019 Numerator Net income (loss) $ 76,713 $ ( 75,240 ) $ ( 152,600 ) Less: undistributed earnings allocated to participating securities ( 4,569 ) - - Less: preferred stock deemed dividend - - ( 3,267 ) Net income (loss) allocable to common stockholders, basic 72,144 ( 75,240 ) ( 155,867 ) Add: undistributed earnings allocated to Series B and warrants 4,569 - - Less: undistributed earnings allocated to Series B and warrants ( 4,190 ) - - Add: interest expense on convertible notes 3,168 - - Less: removal of change in fair value of warrant liability - ( 4,124 ) - Net income (loss) allocable to common stockholders, diluted $ 75,691 $ ( 79,364 ) $ ( 155,867 ) Denominator Weighted average shares used to compute net income (loss) allocable to 116,264 100,753 72,024 Effect of dilutive shares: Stock-based compensation plans 3,075 - - Convertible Notes (as converted to common stock) 13,667 - - Effect of dilutive warrants - 751 - Weighted average shares used to compute net income (loss) allocable to 133,006 101,504 72,024 The following were excluded from the calculation of diluted net income (loss) per share as the effect of their inclusion would have been anti-dilutive: December 31, 2021 2020 2019 Outstanding securities not included in diluted net income (loss) allocable to Stock options and stock awards 5,953 10,299 9,789 Series B Convertible Preferred Stock (as converted to common stock) - 4,140 4,840 Warrants (as exercisable into common stock) 1,883 - 5,841 Convertible Notes (as converted to common stock) - - - |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2021 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Common Stock | 14. Common Stock Common Stock Outstanding As of December 31, 2021, there were 122,945,357 shares of our common stock outstanding. In August 2019, we sold 18,525,000 shares of our common stock, par value $ 0.001 per share, 4,840 shares of our Series B Convertible Preferred Stock, par value $ 0.001 per share (“Series B Preferred Stock”) and warrants to purchase up to an aggregate of 5,841,250 shares of our common stock in an underwritten public offering (the “Offering”) for aggregate net proceeds of approximately $ 65.6 million. Investment funds associated with Bain Capital Life Sciences Investors, LLC (“Bain Capital Life Sciences”) purchased approximately $ 35.0 million of common stock, Series B Preferred Stock and warrants in the Offering on the same terms as the other investors in the Offering. Following the Offering, Andrew A. F. Hack, M.D., Ph.D., a Managing Director of Bain Capital Life Sciences, was appointed to our board of directors. In June 2021, Bain Capital Life Sciences and its affiliates sold warrants to purchase an aggregate of 2,916,250 shares of our common stock for aggregate consideration of $ 11.8 million, representing all of the warrants held by Bain Capital Life Sciences and its affiliates. In May 2020, we completed an underwritten public offering of 16,100,000 shares of our common stock, par value $ 0.001 per share, including 2,100,000 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters. All of the shares were offered at a price to the public of $ 5.00 per share. The net proceeds to us from this offering were approximately $ 75.4 million, after deducting the underwriting discount and other offering expenses payable by us. Bain Life Sciences Funds purchased 1,000,000 shares of common stock in the underwritten public offering. Bain Capital Life Sciences is the general partner of Bain Life Sciences Funds. The participation by Bain Life Sciences Funds was on the same terms as the other investors in the offering. On August 6, 2020, we entered into an at-the-market Sales Agreement (the “2020 ATM Agreement”) with Cowen and Company, LLC (“Cowen”), under which we may offer and sell from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $ 150 million through Cowen as our sales agent. We agreed to pay Cowen a commission of up to 3 % of the gross sales proceeds of any common stock sold through Cowen under the 2020 ATM Agreement. For the year ended December 31, 2021, we received net cash proceeds of $ 28.2 million resulting from sales of 2,878,567 shares of our common stock pursuant to the 2020 ATM Agreement. All of these shares were sold during the three months ended March 31, 2021. As of December 31, 2021, we had $ 120.5 million remaining under the 2020 ATM Agreement. Preferred Stock Outstanding In August 2021, all of the 4,140 shares of Series B Preferred Stock were converted into 4,140,000 shares of common stock. As of December 31, 2021, there were no shares of Series B Preferred Stock outstanding. Warrants During the year ended December 31, 2021, 3,958,650 of our common stock warrants were exercised. There was no exercise of our common stock warrants during the year ended December 31, 2020 and 2019. As of December 31, 2021, the following common stock warrants were outstanding: Warrants Issuance Date Shares Issuable Expiration Date Exercise Price Outstanding as of August 12, 2019 1,883 February 12, 2022 $ 4.50 1,883 As of February 28, 2022, all 1,882,600 of the outstanding warrants as of December 31, 2021 have been exercised or expired resulting in cash settlement of $ 8.5 million. Warrants were exercisable upon issuance. The holder is prohibited from exercising these warrants if, as a result of such exercise, the holder and its affiliates, would own more than 4.99 % of the total number of shares of common stock then issued and outstanding, which percentage may be changed at the holders’ election to a higher or lower percentage (not to exceed 19.99 %) upon 61 days’ notice to the Company. The warrants contain provisions that may obligate us to repurchase them for an amount that does not represent fair value in the event of a change of control. Due to this provision, the warrants do not meet the criteria to be considered indexed to our own stock. Accordingly, we recorded the warrants as a derivative liability. The warrants will be revalued at each reporting period using the Black-Scholes model and the change in the fair value of the warrants will recognized as other income (expense) in the consolidated statements of operations. At December 31, 2021 and 2020, the estimated fair value of warrant liability was $ 18.0 million and $ 10.7 million, respectively. For the year ended December 31, 2021 and 2019, we recognized $ 49.4 million and $ 7.5 million increase in the estimated fair value of warrant liability, respectively, as a loss in other income (expense) in our consolidated statements of operations. For the year ended December 31, 2020, we recognized $ 4.1 million decrease in the estimated fair value of warrant liability as income in other income (expense) in our consolidated statements of operations. |
Equity Plans and Stock-Based Co
Equity Plans and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Equity Plans and Stock-Based Compensation | 15. Equity Plans and Stock-Based Compensation Equity Plans In January 2021, we adopted the Dynavax Technologies Corporation 2021 Inducement Award Plan (“2021 Inducement Plan”), pursuant to which we reserved 1,500,000 shares of common stock for issuance under the plan to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company. In June 2021, we amended the 2021 Inducement Plan (“Amended 2021 Inducement Plan”) to increase the number of shares of common stock reserved under the 2021 Inducement Plan to 3,250,000 . As of December 31, 2021, the 2018 Equity Incentive Plan, as amended, (“Amended 2018 EIP”), the Amended 2021 Inducement Plan and the Amended and Restated 2014 Employee Stock Purchase Plan are our active plans. Under the Amended 2018 EIP, the aggregate number of shares of our common stock that may be issued to employees and directors (subject to adjustment for certain changes in capitalization) is 22,517,869 . The Amended 2018 EIP is administered by our Board of Directors, or a designated committee of the Board of Directors, and awards granted under the Amended 2018 EIP have a term of 7 years unless earlier terminated by the Board of Directors. As of December 31, 2021, there were 4,851,391 shares of common stock reserved for issuance under the Amended 2018 EIP. Activity under our stock plans is set forth below: Shares Underlying Weighted-Average Exercise Weighted-Average Aggregate Balance at December 31, 2020 8,505 $ 11.57 Options granted 3,894 10.49 Options exercised ( 1,035 ) 6.46 Options cancelled: Options forfeited (unvested) ( 521 ) 8.13 Options expired (vested) ( 444 ) 18.48 Balance at December 31, 2021 10,399 $ 11.55 4.16 $ 42,756 Vested and expected to vest at 10,029 $ 11.57 4.08 $ 41,321 Exercisable at December 31, 2021 5,796 $ 13.07 2.64 $ 20,488 The total intrinsic value of stock options exercised during the years ended December 31, 2021, 2020 and 2019 was $ 7.9 million, $ 0.1 million and $ 26,000 , respectively. The total intrinsic value of exercised stock options is calculated based on the difference between the exercise price and the quoted market price of our common stock as of the close of the exercise date. The total fair value of stock options vested during the years ended December 31, 2021, 2020 and 2019 was $ 9.0 million, $ 13.8 million and $ 19.5 million, respectively. Our non-vested stock awards are comprised of restricted stock units granted with performance and time-based vesting criteria. A summary of the status of non-vested restricted stock units as of December 31, 2021, and activities during 2021 are summarized as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2020 1,794 $ 7.23 Granted 1,818 9.50 Vested ( 537 ) 8.85 Forfeited ( 424 ) 8.21 Non-vested as of December 31, 2021 2,651 $ 8.30 Stock-based compensation expense related to restricted stock units was approximately $ 7.9 million for the year ended December 31, 202 1. The aggregate intrinsic value of the restricted stock units outstanding as of December 31, 2021, based on our stock price on that date, was $ 37.3 million. The total fair value of restricted stock units vested during the years ended December 31, 2021, 2020 and 2019 was $ 4.7 million, $ 4.9 million and $ 7.9 million, respectively. We granted performance-based restricted stock unit (“PSU”) to certain executives in February 2021. These PSUs vest upon a specified market condition. The summary of PSU activities for the year ended December 31, 2021 is as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2020 - $ - Granted 297 8.40 Forfeited ( 60 ) 8.40 Non-vested as of December 31, 2021 237 $ 8.40 Stock-based compensation expense related to PSUs was approximately $ 1.8 million for the year ended December 31, 20 21. The aggregate intrinsic value of the PSUs outstanding as of December 31, 2021, based on our stock price on that date, was $ 3.3 million. None of the PSUs vested as of December 31, 2021. Stock-Based Compensation Under our stock-based compensation plans, option awards generally vest over a three-year or four-year period contingent upon continuous service and unless exercised, expire seven or ten years from the date of grant (or earlier upon termination of continuous service). The fair value of each option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value of each RSU is determined at the date of grant using our closing stock price. The fair value of each PSU is estimated using the Monte Carlo simulation method on the date of grant. The weighted-average assumptions used in the calculations of these fair value measurements are as follows: Stock Options Market-Based Performance Stock Unit (“PSUs”) Employee Stock Purchase Plan Year Ended December 31, Year Ended December 31, Year Ended December 31, 2021 2020 2019 2021 2021 2020 2019 Weighted-average fair value $ 7.17 $ 3.91 $ 4.58 $ 8.40 $ 6.48 $ 2.82 $ 2.72 Risk-free interest rate 0.7 % 1.0 % 2.1 % From 0.03 % to 1.92 % 0.1 % 0.9 % 1.9 % Expected life (in years) 4.5 4.5 4.5 2.9 1.2 1.2 1.2 Expected Volatility 0.9 0.9 0.9 0.9 1.0 0.7 0.7 Expected volatility is based on historical volatility of our stock price. The expected life of options granted is estimated based on historical option exercise and employee termination data. Our senior management, who hold a majority of the options outstanding, and other employees were grouped and considered separately for valuation purposes. The risk-free rate for periods within the contractual life of the option is based on the U.S. treasury yield curve in effect at the time of grant. Forfeiture estimates are based on historical employee turnover. The dividend yield is zero percent for all years and is based on our history and expectation of dividend payouts. Compensation expense is based on awards ultimately expected to vest and reflects estimated forfeitures. For equity awards with time-based vesting, the fair value is amortized to expense on a straight-line basis over the vesting periods. Stock-based compensation for the year ended December 31, 2020 included reversal of expenses related to cancellation of certain equity grants in the first quarter of 2020. Stock-based compensation cost for the year ended December 31, 2019 includes incremental cost of $ 4.1 million for accelerated vesting of stock awards and extension of exercise period of stock options in connection with the retirement of our Chief Executive Officer. See Note 17. The Company has also granted performance-based equity awards to certain of our employees. For equity awards with performance-based vesting criteria, the fair value is amortized to expense when the achievement of the vesting criteria becomes probable. No stock-based compensation expense for awards with performance-based vesting criteria was recognized during the year ended December 31, 2021. We recognized stock-based compensation expense for awards with performance-based vesting criteria during the years ended December 31, 2020 and 2019 of $ 0.1 million and $ 0.5 million, respectively. As of December 31, 2021, approximately 117,000 shares underlying stock options and approximately 202,050 restricted stock unit awards with performance-based vesting criteria were outstandin g. None of the awards with performance-based vesting criteria were deemed probable as of December 31, 2021. We recognized the following amounts of stock-based compensation expense (in thousands): Year Ended December 31, 2021 2020 2019 Employees and directors stock-based compensation expense $ 21,285 $ 13,484 $ 25,456 Year Ended December 31, 2021 2020 2019 Research and development $ 3,818 $ 1,000 $ 8,058 Selling, general and administrative 14,894 9,585 10,224 Cost of sales - product 553 619 1,088 Inventory 2,020 2,280 1,964 Restructuring - - 4,122 Total $ 21,285 $ 13,484 $ 25,456 As of December 31, 2021, the total unrecognized compensation cost related to non-vested stock options and awards deemed probable of vesting, including all stock options with time-based vesting, net of estimated forfeitures, amounted to $ 33.0 million, which is expected to be recognized over the remaining weighted-average vesting period of 2 years . As of December 31, 2021, the total unrecognized compensation cost related to equity awards with performance-based vesting criteria amounted to $ 1.0 million. As of December 31, 2021, the total unrecognized compensation cost related to PSUs amounted to $ 0.2 million. Employee Stock Purchase Plan The Amended and Restated 2014 Employee Stock Purchase Plan (the “Employee Stock Purchase Plan”) provides for the purchase of common stock by eligible employees. In May 2021, our stockholders approved the amendment and restatement of the Employee Stock Purchase Plan to increase the authorized number of shares of common stock by 1,000,000 . The maximum number of shares of common stock that may be issued under the Employee Stock Purchase Plan will not exceed 1,850,000 shares of common stock. The purchase price per share is the lesser of (i) 85 % of the fair market value of the common stock on the commencement of the two-year offer period (generally, the sixteenth day in February or August) or (ii) 85 % of the fair market value of the common stock on the exercise date, which is the last day of a purchase period (generally, the fifteenth day in February or August). For the year ended December 31, 2021, employees have acquired 217,270 shares of our common stock under the Employee Stock Purchase Plan and 1,038,313 shares of our common stock remained available for future purchases under the Employee Stock Purchase Plan. As of December 31, 2021, the total unrecognized compensation cost related to shares of our common stock under the Employee Stock Purchase Plan amounted to $ 1.1 million, which is expected to be recognized over the remaining weighted-average vesting period of 1.5 years. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2021 | |
Pension and Other Postretirement Benefits Cost (Reversal of Cost) [Abstract] | |
Employee Benefit Plan | 16. Employee Benefit Plan We maintain a 401(k) Plan, which qualifies as a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. Under the 401(k) Plan, participating employees may defer a portion of their pretax earnings. We may, at our discretion, contribute for the benefit of eligible employees. The Company’s contribution to the 401(k) Plan was approximately $ 0.3 million, $ 0.2 million and $ 0.3 million for the years ended December 31, 2021, 2020 and 2019, respectively. |
Restructuring
Restructuring | 12 Months Ended |
Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | 17. Restructuring On May 23, 2019, we implemented a strategic organizational restructuring, principally to align our operations around our vaccine business and significantly curtail further investment in our immuno-oncology business. In connection with the restructuring, we reduced our workforce by approximately 80 positions, or approximately 36 %, of U.S.-based personnel. Also, in connection with the restructuring, our Chief Executive Officer, also a member of the Board of Directors (the “Board”), submitted notice of his retirement from the Company and the Board, effective August 1, 2019. As of December 31, 2020 , we have completed our restructuring activities and all costs have been incurred. The major components of our restructuring costs are summarized as follows (in thousands): Components of Restructuring Costs Restructuring Costs Severance and other termination benefits $ 6,277 Stock-based compensation expense (a) 4,122 Accelerated depreciation 2,957 Total restructuring cost $ 13,356 (a) As a result of accelerated vesting of stock awards and the extension of exercise period of stock options |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 18. Income Taxes Consolidated income (loss) before provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2021 2020 2019 U.S. $ 75,954 $ ( 76,324 ) $ ( 154,605 ) Non U.S. 1,567 1,084 2,005 Total $ 77,521 $ ( 75,240 ) $ ( 152,600 ) There was no income tax provision for the years ended December 31, 2020 and 2019. The components of the consolidated income tax provision for the year ended December 31, 2021 were as follows (in thousands): Year Ended December 31, 2021 Current Federal $ 345 State 260 Non-US 203 Total current tax expense 808 Deferred Federal - State - Non-US - Total deferred tax expense - Total income tax expense $ 808 No income tax expense was recorded for the years ended December 31, 2020 and 2019 due to a full valuation allowance. The difference between the consolidated income tax provision (benefit) and the amount computed by applying the federal statutory income tax rate to the consolidated income before income taxes was as follows (in thousands): Year Ended December 31, 2021 2020 2019 Income tax provision (benefit) at federal statutory rate $ 16,397 $ ( 15,756 ) $ ( 32,046 ) State tax 3,576 ( 3,194 ) ( 3,153 ) Business credits ( 982 ) ( 773 ) ( 1,757 ) Uncertain tax positions 424 193 5,426 Deferred compensation charges 131 809 4,600 Change in valuation allowance ( 86,847 ) 19,009 22,715 Section 162(m) limitation 1,241 473 2,439 Mark-to-market of warrants 10,364 ( 866 ) 1,575 Net operating loss and tax credit limitation 56,459 - - Other 45 105 201 Total income tax expense $ 808 $ - $ - Deferred tax assets and liabilities consisted of the following (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 155,503 $ 224,161 Research credit carryforwards 12,870 28,578 Lease liability 8,515 - Stock compensation 5,798 - Accruals and reserves 5,792 17,264 Other 212 3,250 Total deferred tax assets 188,690 273,253 Less valuation allowance ( 179,253 ) ( 266,100 ) Net deferred tax assets 9,437 7,153 Deferred tax liabilities: Fixed assets ( 3,283 ) ( 275 ) Operating lease right-of-use assets ( 6,124 ) ( 6,878 ) Other ( 30 ) - Total deferred tax liabilities ( 9,437 ) ( 7,153 ) Net deferred tax assets $ - $ - The tax benefit of net operating losses, temporary differences and credit carryforwards is required to be recorded as an asset to the extent that management assesses that realization is "more likely than not." Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carryforward period. A high degree of judgment is required to determine if, and the extent to which, valuation allowances should be recorded against deferred tax assets. In making such determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. Based on all available evidence, both positive and negative, and the weight of that evidence to the extent such evidence can be objectively verified, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not more likely than not to be realized and, accordingly, has provided a valuation allowance. Given our current earnings, management believes that, within the next twelve months, sufficient positive evidence may become available to allow management to reach a conclusion that a portion of the valuation allowance recorded against the deferred tax assets held may be reversed. A reversal would result in an income tax benefit for the quarterly and annual fiscal period in which we release the valuation allowance. However, the exact timing and amount of a valuation allowance release are subject to change on the basis of the level of profitability that we actually achieve. The valuation allowance decreased by $ 86.8 million during the year ended December 31, 2021 and increased by $ 19.0 million during the year ended December 31, 2020. The decrease in valuation allowance during the year ended December 31, 2021 was due to a decrease in our deferred tax assets, predominantly related to utilization of net operating losses and Section 382 limitations. As of December 31, 2021, we had federal net operating loss carryforwards of approximately $ 303.8 million which begin to expire in the year 2022 , federal net operating loss carryforwards of approximately $ 333.4 million, which do not expire and federal research and development tax credits of approximately $ 1.9 million, which expire in the years 2022 through 2041 . As of December 31, 2021, we had net operating loss carryforwards for California and other states for income tax purposes of approximately $ 345.9 million, which expire in the years 2022 through 2041 , and California state research and development tax credits of approximately $ 19.6 million, which do not expire. As of December 31, 2021, we had net operating loss carryforwards for foreign income tax purposes of approximately $ 3.5 million, which do not expire. Uncertain Income Tax positions The total amount of unrecognized tax benefits was $ 5.6 million and $ 10.6 million as of December 31, 2021 and 2020, respectively. If recognized, none of the unrecognized tax benefits would affect the effective tax rate. The following table summarizes the activity related to our unrecognized tax benefits: Balance at December 31, 2020 $ ( 10,565 ) Tax positions related to the current year Additions ( 308 ) Reductions - Tax positions related to the prior year Additions - Reductions 5,258 Settlements - Lapses in statute - Balance at December 31, 2021 $ ( 5,615 ) Our policy is to account for interest and penalties as income tax expense. As of December 31, 2021, there was no interest and $ 0.2 million of penalties recognized in the provision for income taxes. As of December 31, 2020, there was no interest or penalties related to unrecognized tax benefits recognized in the provision for income taxes. We do not anticipate any significant change within 12 months of this reporting date of its uncertain tax positions. The Tax Reform Act of 1986 limits the annual use of net operating loss and tax credit carryforwards in certain situations where changes occur in stock ownership of a company. In the event there is a change in ownership, as defined, the annual utilization of such carryforwards could be limited. Based on an analysis under Section 382 of the Internal Revenue Code, completed through December 31, 2021, we experienced ownership changes in 2008, 2009, 2012, and 2019 which limit the future use of our pre-change federal and state net operating loss carryforwards and federal research and development tax credits. We excluded the net operating loss carryforwards and research and development tax credits that will expire as a result of the annual limitations in the deferred tax assets and corresponding uncertain tax positions as of December 31, 2021. We are subject to income tax examinations for U.S. federal and state income taxes from 2002 forward. We are subject to tax examination in Germany from 2018 forward and in India from 2019 forward. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and include our accounts and those of our wholly-owned subsidiaries, Dynavax GmbH located in Düsseldorf, Germany and Dynavax India LLP in India. All significant intercompany accounts and transactions among the entities have been eliminated from the consolidated financial statements. We operate in one business segment: discovery, development and commercialization of innovative vaccines. |
Liquidity and Financial Condition | Liquidity and Financial Condition As of December 31, 2021, we had cash, cash equivalents and marketable securities of $ 546.0 million. In May 2021, we issued $ 225.5 million in 2.50 % convertible senior notes due 2026 (“Convertible Notes”). We used approximately $ 190.2 million of the net proceeds to retire our previous loan agreement with CRG Servicing LLC ("Loan Agreement") (see Note 11) and $ 27.2 million of the net proceeds to pay the costs of the capped call transactions (the “Capped Calls”) (see Note 10). As of December 31, 2021, the aggregate principal amount of our Convertible Notes was $ 225.5 million, excluding debt discount of $ 5.0 million (see Note 10). The Convertible Notes mature on May 15, 2026 , unless converted, redeemed or repurchased in accordance with their terms prior to such date. Prior to January 1, 2021, we incurred net losses in each year since our inception. For the year ended December 31, 2021, we recorded net income of $ 76.7 million. We cannot be certain that sales of our products, and the revenue from our other activities are sustainable. Further, we expect to continue to incur substantial expenses as we continue to invest in commercialization of HEPLISAV-B, development and procurement of our CpG 1018 adjuvant, and clinical trials and other development. If we cannot generate a sufficient amount of revenue from product sales, we will need to finance our operations through strategic alliance and licensing arrangements and/or future public or private debt and equity financings. Adequate financing may not be available to us on acceptable terms, or at all. We currently anticipate that our cash, cash equivalents and short-term marketable securities as of December 31, 2021, and anticipated revenues from HEPLISAV-B and CpG 1018 will be sufficient to fund our operations for at least the next 12 months from the date of this filing. Our ability to raise additional capital in the equity and debt markets, should we choose to do so, is dependent on a number of factors, including, but not limited to, the market demand for our common stock, which itself is subject to a number of development and business risks and uncertainties, our creditworthiness and the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us. In addition, our ability to raise additional funds may be adversely impacted by deteriorating global economic conditions and the recent or future disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic or otherwise. Raising additional funds through the issuance of equity or debt securities could result in dilution to our existing stockholders, increased fixed payment obligations, or both. In addition, these securities may have rights senior to those of our common stock and could include covenants that would restrict our operations. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management’s estimates are based on historical information available as of the date of the consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. Actual results could differ materially from these estimates. |
Foreign Currency Translation | Foreign Currency Translation We consider the local currency to be the functional currency for our international subsidiaries, Dynavax GmbH and Dynavax India LLP. Accordingly, assets and liabilities denominated in this foreign currency are translated into U.S. dollars using the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at average exchange rates prevailing during the year. Currency translation adjustments arising from period to period are charged or credited to accumulated other comprehensive income (loss) in stockholders’ equity. As of December 31, 2021 and 2020, the cumulative translation adjustments balance was $( 2.3 ) million and $ 0.2 million, respectively, primarily related to the translation of Dynavax GmbH assets, liabilities and operating results from Euros to U.S. dollars. For the years ended December 31, 2021, 2020 and 2019, we reported an unrealized (loss) gain of $( 2.5 ) million, $ 2.7 million and $( 0.5 ) million, respectively. Realized gains and losses resulting from currency transactions are included in other income (expense) in the consolidated statements of operations. For the years ended December 31, 2021, 2020 and 2019, we reported a gain (loss) of $ 0.9 million, $( 0.8 ) million and $ 0.2 million, respectively, resulting from currency transactions in our consolidated statements of operations. |
Cash, Cash Equivalents, and Marketable Securities | Cash, Cash Equivalents and Marketable Securities We consider all liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. Management determines the appropriate classification of marketable securities at the time of purchase. In accordance with our investment policy, we invest in short-term money market funds, U.S. treasuries, U.S. government agency securities and corporate debt securities. We believe these types of investments are subject to minimal credit and market risk. We have classified our entire investment portfolio as available-for-sale and available for use in current operations and accordingly have classified all investments as short-term. Available-for-sale securities are carried at fair value based on inputs that are observable, either directly or indirectly, such as quoted market prices for similar securities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the securities, with unrealized gains and losses included in accumulated other comprehensive loss i n stockholders’ equity. Realized gains and losses and declines in value, if any, judged to be other than temporary on available-for-sale securities are included in interest income or expense. The cost of securities sold is based on the specific identification method. Management assesses whether declines in the fair value of investment securities are other than temporary. In determining whether a decline is other than temporary, management considers the following factors: • whether the investment has been in a continuous realized loss position for over 12 months; • the duration to maturity of our investments; • our intention and ability to hold the investment to maturity and if it is not more likely than not that we will be required to sell the investment before recovery of the amortized cost bases; • the credit rating, financial condition and near-term prospects of the issuer; and • the type of investments made. To date, there have been no declines in fair value that have been identified as other than temporary. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents, marketable securities and accounts receivable. Our policy is to invest cash in institutional money market funds and marketable securities of the U.S. government and corporate issuers with high credit quality to limit the amount of credit exposure. We currently maintain a portfolio of cash equivalents and marketable securities in a variety of securities, including short-term money market funds, U.S. treasuries, U.S. government agency securities and corporate debt securities. We have not experienced any losses on our cash equivalents and marketable securities. Our accounts receivable balance consists, primarily, of amounts due from product sales. Accounts receivable are recorded net of reserves for chargebacks, distribution fees, trade discounts and doubtful accounts. We estimate our allowance for doubtful accounts based on an evaluation of the aging of our receivables. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. To date, we have not recorded any allowance for doubtful accounts. As of December 31, 2021 and 2020, three customers collectively represented approximately 76 % and 86 % of our HEPLISAV-B trade receivable balance, respectively. As of December 31, 2021 and 2020, one customer represented approximately 94 % and 100 % of our CpG 1018 trade receivable balance, respectively. Our product candidates will require approval from the United States Food and Drug Administration ("FDA") and foreign regulatory agencies before commercial sales can commence. There can be no assurance that our products will receive any of these required approvals. The denial or delay of such approvals may have a material adverse impact on our business and may impact our business in the future. In addition, after the approval of HEPLISAV-B by the FDA, there is still an ongoing risk of adverse events that did not appear during the drug approval process. We are subject to risks common to companies in the biopharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of product candidates, product liability, the volatility of our stock price and the need to obtain additional financing. As of December 31, 2021 and 2020, 43 % and 57 %, respectively, of our long-lived assets were located in the United States and the remaining long-lived assets were located in Germany. |
Inventories, net | Inventories, net HEPLISAV-B Inventories, net Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain an d if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. Additionally, for the year ended December 31, 2021, due to the COVID-19 pandemic and its prolonged impact on vaccine utilization and corresponding revisions to our sales forecast, we recorded an approximately $2.6 million write-off to cost of sales – product associated with HEPLISAV-B slow moving short-dated inventory that had been manufactured prior to the beginning of the COVID-19 pandemic. For the year ended December 31, 2020 and 2019, there were no inventory write-offs recognized. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to the required regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. HEPLISAV-B was approved by the United States Food and Drug Administration (“FDA”) on November 9, 2017, at which time we began to capitalize inventory costs associated with the vial presentation of HEPLISAV-B. In March 2018, we received regulatory approval of the pre-filled syringe (“PFS”) presentation of HEPLISAV-B. Prior to FDA approval of HEPLISAV-B, all costs related to the manufacturing of HEPLISAV-B that could potentially be available to support the commercial launch of our products, were charged to research and development expense in the period incurred as there was no alternative future use. Prior to regulatory approval of PFS, costs associated with resuming operating activities at the Düsseldorf manufacturing facility were also included in research and development expense. Subsequent to regulatory approval of PFS, costs associated with resuming manufacturing activities at the Düsseldorf facility were included in cost of sales – product, until commercial production resumed in mid-2018 at which time these costs were recorded as raw materials inventory. CpG 1018 Inventories, net Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the year ended December 31, 2021 and 2020, there were no inventory reserves recognized. |
Long-Lived Assets | Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. We evaluate the carrying value of long-lived assets, whenever events or changes in business circumstances or our planned use of long-lived assets indicate, based on undiscounted future operating cash flows, that their carrying amounts may not be fully recoverable or that their useful lives are no longer appropriate. When an indicator of impairment exists, undiscounted future operating cash flows of long-lived assets are compared to their respective carrying value. If the carrying value is greater than the undiscounted future operating cash flows of long-lived assets, the long-lived assets are written down to their respective fair values and an impairment loss is recorded. Fair value is determined primarily using the discounted cash flows expected to be generated from the use of assets. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected cash flows. In the third quarter of 2019, we recorded accelerated depreciation of $ 3.0 million related to certain long-lived assets in connection with our restructuring. See Note 17. There was no accelerated depreciation recorded during the year ended December 31, 2021 and 2020. |
Leases | Leases We determine if an arrangement includes a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities and long-term portion of lease liabilities in our consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, we use our incremental borrowing rate which represents an estimated rate of interest that we would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude any lease incentives. Our leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that we will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. We have elected not to apply the recognition requirements of ASC 842 for short-term leases. We have also elected the practical expedient to not separate lease components from non-lease components. As lessors, we determine if an arrangement includes a lease at inception. We elected the practical expedient to not separate lease components from non-lease components. Sublease income is recognized on a straight-line basis over the expected lease term and is included in other income (expense) in our consolidated statements of operations. |
Goodwill | Goodwill Our goodwill balance relates to our April 2006 acquisition of Dynavax GmbH. Goodwill represents the excess purchase price over the fair value of tangible and intangible assets acquired and liabilities assumed. Goodwill is not amortized but is subject to an annual impairment test. In performing its goodwill impairment review, we assess qualitative factors to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill. The qualitative factors include, but are not limited to macroeconomic conditions, industry and market considerations, and the overall financial performance of the Company. If after assessing the totality of these qualitative factors, we determine that it is not more likely than not that the fair value of its reporting unit is less than its carrying amount, then no additional assessment is deemed necessary. Otherwise, we will proceed to perform a test for goodwill impairment. The first step involves comparing the estimated fair value of the related reporting unit against its carrying amount including goodwill. If the carrying amount exceeds the fair value, the amount by which the carrying amount exceeds the reporting unit’s fair value is recorded as a charge in the consolidated statements of operations. We determined that we have only one operating segment and there are no components of that operating segment that are deemed to be separate reporting units such that we have one reporting unit for purposes of our goodwill impairment testing. We evaluate goodwill for impairment on an annual basis and on an interim basis if events or changes in circumstances between annual impairment tests indicate that the asset might be impaired. No impairment has been identified for the years presented. |
Convertible Notes | Convertible Notes We accounted for the Convertible Notes (see Note 10) as a long-term liability equal to the proceeds received from issuance, including the embedded conversion feature, net of the unamortized debt issuance and offering costs on the consolidated balance sheets. We evaluate all conversion, repurchase and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative. The conversion feature is not required to be accounted for separately as an embedded derivative. We amortize debt issuance and offering costs over the contractual term of the Convertible Notes, using the effective interest method, as interest expense on the consolidated statements of operations. |
Capped Calls | Capped Calls We evaluate financial instruments under ASC 815. In May 2021, in connection with the issuance of the Convertible Notes, we entered into the Capped Calls (see Note 10). The Capped Calls cover the same number of shares of common stock that initially underlie the Convertible Notes (subject to anti-dilution and certain other adjustments). The Capped Calls meet the definition of derivative under ASC 815. In addition, the Capped Calls meet the conditions in ASC 815 to be classified in stockholders’ equity and are not subsequently remeasured as long as the conditions for the equity classification continue to be met. |
Revenue Recognition | Revenue Recognition We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of Accounting Standards Codification (“ASC”) 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net – HEPLISAV-B We sell HEPLISAV-B to a limited number of wholesalers and specialty distributors in the U.S. (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one-year , there is no significant financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates and other fees that are offered within contracts between us and our Customers, healthcare providers, pharmacies and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. We evaluate our estimates of variable considerations including, but not limited to, product returns, chargebacks and rebates, periodically or when there is an event or change in circumstances that may indicate that our estimates may change. Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product that has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory and other relevant factors. There were no material adjustments to these estimates for the years ended December 31, 2021 and 2019. During the fourth quarter of 2020, based on an analysis of historical product returns and customer ordering patterns, we decreased our returns reserve resulting in an increase in HEPLISAV-B product revenue, net of approximately $ 0.8 million. Chargebacks: Our Customers subsequently resell our product to healthcare providers, pharmacies and others. In addition to distribution agreements with Customers, we enter into arrangements with qualified healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare providers by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to the qualified healthcare providers, and chargebacks for units that our Customers have sold to the qualified healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances: We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees: Distribution fees include fees paid to certain Customers for sales order management, data and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Rebates: Under certain contracts, customers may obtain rebates for purchasing minimum volumes of our product. We estimate these rebates based upon the expected purchases and the contractual rebate rate and record this estimate as a reduction in revenue in the period the related revenue is recognized. Product Revenue, Net – CpG 1018 We also sell our novel adjuvant, CpG 1018, to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccine. We have determined that our collaboration partners meet the definition of customers under ASC 606. Therefore, we accounted for our CpG 1018 sales under ASC 606. Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product to the customer. Because the timing between the recognition of revenue for product sales and the receipt of payment is less than one year, there is no significant financing component on the related receivables. Since our performance obligation is part of a contract that has an original expected duration of one year or less, we elect not to disclose the information about our remaining performance obligations. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Other Revenue Other revenue includes grant, collaboration and manufacturing service revenue. We have entered into grant agreements, collaborative arrangements and arrangements to provide manufacturing services to other companies. Such arrangements may include promises to customers which, if capable of being distinct, are accounted for as separate performance obligations. For agreements with multiple performance obligations, we allocate estimated revenue to each performance obligation at contract inception based on the estimated transaction price of each performance obligation. Revenue allocated to each performance obligation is then recognized when we satisfy the performance obligation by transferring control of the promised good or service to the customer. |
Research and Development Expenses and Accruals | Research and Development Expenses and Accruals Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. We contract with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to our vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. Our accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. We may terminate these contracts upon written notice and we are generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances we may be further responsible for termination fees and penalties. We estimate research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to us at that time. There have been no material adjustments to the prior period accrued estimates for clinical trial activities during the years presented. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for restricted stock units ("RSUs") and stock options is estimated at the grant date based on the award’s estimated fair value. For awards that vest based on service conditions and market conditions, the Company uses a straight-line method to recognize compensation expense over the award’s requisite service period, assuming estimated forfeiture rates. For awards that contain performance conditions, the Company determines the appropriate amount to expense at each reporting date based on the anticipated achievement of performance targets, which requires judgement, including forecasting the achievement of future specified targets. At the date performance conditions are determined to be probable of achievement, the Company records a cumulative expense catch-up, with remaining expense amortized over the remaining service period. Throughout the performance period, the Company re-assesses the estimated performance and updates the number of performance-based awards that it believes will ultimately vest. Fair value of restricted stock units is determined at the date of grant using the Company’s closing stock price, with the exception of performance-based RSUs with market conditions, which are measured using the Monte Carlo simulation method on the date of grant. Our determination of the fair value of stock options on the date of grant using an option-pricing model is affected by our stock price, as well as assumptions regarding a number of subjective variables. We selected the Black-Scholes option pricing model as the most appropriate method for determining the estimated fair value-based measurement of our stock options. The Black-Scholes model requires the use of subjective assumptions which determine the fair value-based measurement of stock options. These assumptions include, but are not limited to, our expected stock price volatility over the term of the awards, and projected employee stock option exercise behaviors. In the future, as additional empirical evidence regarding these input estimates becomes available, we may change or refine our approach of deriving these input estimates. These changes could impact our fair value of stock options granted in the future. Changes in the fair value of stock awards could materially impact our operating results. Our current estimate of volatility is based on the historical volatility of our stock price. To the extent volatility in our stock price increases in the future, our estimates of the fair value of options granted in the future could increase, thereby increasing stock-based compensation cost recognized in future periods. We derive the expected term assumption primarily based on our historical settlement experience, while giving consideration to options that have not yet completed a full life cycle. Stock-based compensation cost is recognized only for awards ultimately expected to vest. Our estimate of the forfeiture rate is based primarily on our historical experience. To the extent we revise this estimate in the future, our share-based compensation cost could be materially impacted in the period of revision. There have been no material adjustments to these estimates during the years presented. |
Income Taxes | Income Taxes The asset and liability approach is used to recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax bases of assets and liabilities. Tax law and rate changes are reflected in income in the period such changes are enacted. We include interest and penalties related to income taxes, including unrecognized tax benefits, within income tax expense. Our income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax regulations. We recognize liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While we believe we have appropriate support for the positions taken on our tax returns, we regularly assess the potential outcomes of examinations by tax authorities in determining the adequacy of our provision for income taxes. We continually assess the likelihood and amount of potential adjustments and adjust the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. Significant judgment is required in determining our provision for income taxes, our deferred tax assets and liabilities and the valuation allowance recorded against our net deferred tax assets. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis and includes a review of all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. Based on all available evidence, both positive and negative, and the weight of that evidence to the extent such evidence can be objectively verified, we believe that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not more likely than not to be realized and, accordingly, we have determined a need for a full valuation allowance. Given our current earnings, we believe that, within the next twelve months, sufficient positive evidence may become available to allow us to reach a conclusion that a portion of the valuation allowance recorded against the deferred tax assets held may be reversed. A reversal would result in an income tax benefit for the quarterly and annual fiscal period in which we determine to release the valuation allowance. However, the exact timing and amount of a valuation allowance release are subject to change on the basis of the level of profitability that we actually achieve. |
Restructuring | Restructuring Restructuring costs are comprised of severance, other termination benefit costs, stock-based compensation expense for stock award and stock option modifications related to workforce reductions and accelerated depreciation. We recognize restructuring charges when the liability is probable and the amount is estimable. Employee termination benefits are accrued at the date management has committed to a plan of termination and affected employees have been notified of their termination date and expected severance benefits. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Update 2019-12 In December 2019, the FASB issued Accounting Standards Update (“ASU”) No. 2019-12, Simplifying the Accounting for Income Taxes (Topic 740). This ASU simplifies the accounting for income taxes by removing certain exceptions and improving consistent application in certain areas of Topic 740. The ASU is effective for annual periods beginning after December 15, 2020 with early adoption permitted. We adopted this ASU on January 1, 2021 and the adoption of this standard did not have a material impact on our consolidated financial statements. Accounting Standards Update 2020-06 We adopted ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity on January 1, 2021 using the modified retrospective method. This ASU simplifies the accounting for convertible instruments and requires entities to use the if-converted method for all convertible instruments in calculating diluted earnings-per-share. Entities also need to recombine instruments that were previously separated into two units of account if separation is no longer required. The adoption of this ASU did not have a material impact on our consolidated financial statements as there were no outstanding financial instruments that require recombination at January 1, 2021. Accounting Standards Update 2016-13 In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments. The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. For public business entities, excluding smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2019. Furthermore, the one-time determination of whether an entity is eligible to be a smaller reporting company shall be based on an entity’s most recent determination as of November 15, 2019, in accordance with SEC regulations. Because we were a smaller reporting company based on the most recent determination as of November 15, 2019, this ASU and its subsequent updates, will be effective for fiscal years beginning after December 15, 2022. We are currently evaluating the impact this standard will have on our consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) and liabilities measured at fair value on a recurring basis (in thousands): Level 1 Level 2 Level 3 Total December 31, 2021 Assets Money market funds $ 429,194 $ - $ - $ 429,194 U.S. treasuries - 4,004 - 4,004 U.S. government agency securities - 26,548 - 26,548 Corporate debt securities - 79,209 - 79,209 Total assets $ 429,194 $ 109,761 $ - $ 538,955 Liabilities Warrant liability $ - $ - $ 18,016 $ 18,016 Level 1 Level 2 Level 3 Total December 31, 2020 Assets Money market funds $ 23,128 $ - $ - $ 23,128 U.S. treasuries - 32,579 - 32,579 U.S. government agency securities - 40,321 - 40,321 Corporate debt securities - 61,063 - 61,063 Total assets $ 23,128 $ 133,963 $ - $ 157,091 Liabilities Warrant liability $ - $ - $ 10,736 $ 10,736 |
Summary of Assumptions to Estimate the Fair Value of Warrant Liability | As of December 31, 2021, we used the following key assumptions to estimate the fair value of warrant liability: Number of shares 1,882,600 Expected term 0.1 years Expected volatility 0.7 Risk-free interest rate 0.1 % Dividend yield 0 % |
Summary of Changes in Fair Value Warrant liability | The following table provides a summary of changes in the fair value warrant liability for year ended December 31, 2021 and 2020 (in thousands): Balance at December 31, 2019 $ 14,860 Decrease in estimated fair value of warrant liability upon revaluation ( 4,124 ) Balance at December 31, 2020 $ 10,736 Decrease in fair value of warrants exercised ( 4,765 ) Warrants exercised ( 42,074 ) Increase in the estimated fair value of warrant liability upon revaluation 54,119 Balance at December 31, 2021 $ 18,016 |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statements of cash flows: December 31 2021 2020 2019 Cash and cash equivalents $ 436,189 $ 32,073 $ 39,884 Restricted cash 219 237 216 Total cash, cash equivalents and restricted cash shown in the $ 436,408 $ 32,310 $ 40,100 |
Summary of Cash, Cash Equivalents and Marketable Securities | Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Unrealized Unrealized Estimated December 31, 2021 Cash and cash equivalents: Cash $ 6,995 $ - $ - $ 6,995 Money market funds 429,194 - - 429,194 Total cash and cash equivalents 436,189 - - 436,189 Marketable securities available-for-sale: U.S. treasuries 4,005 - ( 1 ) 4,004 U.S. government agency securities 26,555 - ( 7 ) 26,548 Corporate debt securities 79,200 9 - 79,209 Total marketable securities available-for-sale 109,760 9 ( 8 ) 109,761 Total cash, cash equivalents and marketable securities $ 545,949 $ 9 $ ( 8 ) $ 545,950 December 31, 2020 Cash and cash equivalents: Cash $ 7,945 $ - $ - $ 7,945 Money market funds 23,128 - - 23,128 Corporate debt securities 1,000 - - 1,000 Total cash and cash equivalents 32,073 - - 32,073 Marketable securities available-for-sale: U.S. treasuries 32,548 31 - 32,579 U.S. government agency securities 40,313 14 ( 6 ) 40,321 Corporate debt securities 60,071 3 ( 11 ) 60,063 Total marketable securities available-for-sale 132,932 48 ( 17 ) 132,963 Total cash, cash equivalents and marketable securities $ 165,005 $ 48 $ ( 17 ) $ 165,036 |
Maturities of Marketable Securities Available-for-Sale | The maturities of our marketable securities available-for-sale are as follows (in thousands): . December 31, 2021 Amortized Estimated Mature in one year or less $ 109,760 $ 109,761 Mature after one year through two years - - $ 109,760 $ 109,761 |
Inventories, Net (Tables)
Inventories, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table presents inventories, net (in thousands): December 31 2021 2020 Raw materials $ 26,637 $ 25,121 Work-in-process 14,748 30,293 Finished goods 19,950 8,275 Total $ 61,335 $ 63,689 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Component of Property and Equipment, Net | Property and equipment consist of the following (in thousands): Estimated Useful December 31, Life 2021 2020 Manufacturing equipment 5 - 13 $ 12,532 $ 13,884 Lab equipment 5 - 13 2,492 2,888 Computer equipment 3 5,336 5,255 Furniture and fixtures 3 - 13 2,463 2,510 Leasehold improvements 2 - 10 27,634 28,417 Assets in progress 9,941 1,024 60,398 53,978 Less accumulated depreciation and amortization ( 25,378 ) ( 23,411 ) Total $ 35,020 $ 30,567 |
Current Accrued Liabilities a_2
Current Accrued Liabilities and Accrued Research and Development (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Component Of Current Accrued Liabilities And Accrued Research And Development [Abstract] | |
Component of Current Accrued Liabilities | Current accrued liabilities consist of the following (in thousands): December 31, 2021 2020 Payroll and related expenses $ 13,011 $ 8,684 Revenue reserve accruals 8,253 6,040 Accrued inventory 20,868 338 Other accrued liabilities 7,664 4,037 Total $ 49,796 $ 19,099 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Operating Lease Expense | Our lease expense comprises of the following (in thousands): Year Ended December 31, 2021 2020 2019 Operating lease expense $ 6,265 $ 6,267 $ 6,886 |
Summary of Balance Sheet Classification of Operating Lease Liabilities | The balance sheet classification of our operating lease liabilities was as follows (in thousands): December 31, 2021 December 31, 2020 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 2,577 $ 3,247 Long-term portion of lease liabilities 34,316 34,789 Total operating lease liabilities $ 36,893 $ 38,036 |
Summary of Maturities of Sublease Income and Operating Lease Liabilities | At December 31, 2021, the maturities of our sublease income and operating lease liabilities were as follows (in thousands): Years ending December 31, Sublease Income Operating Lease 2022 $ 5,357 $ 6,174 2023 5,518 5,634 2024 5,684 5,778 2025 5,854 5,927 2026 6,030 6,080 Thereafter 27,712 28,259 Total $ 56,155 57,852 Less: Present value adjustment ( 20,959 ) Total $ 36,893 |
Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate | The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liability were as follows: December 31, 2021 December 31, 2020 Weighted average remaining lease term 9.1 years 9.1 years Weighted average discount rate 10.1 % 10.1 % |
Schedule of Material Purchase Commitments | The following summarizes our material purchase commitments at December 31, 2021 and the effect those obligations are expected to have on our liquidity and cash flows in future periods (in thousands): Years ending December 31, (in thousands) 2022 $ 55,318 2023 9,312 2024 10,857 2025 11,367 2026 11,872 Thereafter - Total 98,726 |
Convertible Notes (Tables)
Convertible Notes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Interest Expenses Related to Convertible Notes | The following table presents the components of interest expense related to Convertible Notes (in thousands): Year Ended December 31, 2021 Stated coupon interest $ 3,555 Amortization of debt issuance cost 669 Total interest expense $ 4,224 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Disaggregation of Revenues | The following table disaggregates our product revenue, net by product and geographic region and disaggregates our other revenues by geographic region (in thousands): Year Ended Year Ended Year Ended December 31, 2021 December 31, 2020 December 31, 2019 U.S. Non U.S. Total U.S. Non U.S. Total U.S. Non U.S. Total Product revenue, net HEPLISAV-B $ 61,870 $ - $ 61,870 $ 36,030 $ - $ 36,030 $ 34,644 $ - $ 34,644 CpG 1018 - 375,229 375,229 - 3,277 3,277 - - - Total product revenue, net $ 61,870 $ 375,229 $ 437,099 $ 36,030 $ 3,277 $ 39,307 $ 34,644 $ - $ 34,644 Other revenue 1,915 428 2,343 - 7,244 7,244 410 165 575 Total revenues $ 63,785 $ 375,657 $ 439,442 $ 36,030 $ 10,521 $ 46,551 $ 35,054 $ 165 $ 35,219 |
HEPLISAV-B | |
Schedule of Revenues from Major Customers | The following table summarizes HEPLISAV-B product revenue from each of our three largest Customers (as a percentage of total HEPLISAV-B product revenue): Year Ended December 31, 2021 2020 2019 Largest Customer 21 % 21 % 22 % Second largest Customer 19 % 20 % 21 % Third largest Customer 19 % 20 % 19 % |
Summary of Product Revenue Allowance and Reserve Categories | Balance at Provisions Credit or payments Balance Year ended December 31, 2021: Accounts receivable reserves(1) $ 2,836 $ 18,209 $ ( 17,222 ) $ 3,823 Revenue reserve accruals(2) $ 6,040 $ 13,077 $ ( 10,864 ) $ 8,253 Year ended December 31, 2020: Accounts receivable reserves(1) $ 2,701 $ 11,417 $ ( 11,282 ) $ 2,836 Revenue reserve accruals(2) $ 3,893 $ 6,694 $ ( 4,547 ) $ 6,040 (1) Reserves are for chargebacks, discounts and other fees. (2) Accruals are for returns, rebates and other fees. |
CpG 1018 | |
Schedule of Revenues from Major Customers | The following table summarizes CpG 1018 product revenue from each of our three largest collaboration partners (as a percentage of total CpG 1018 product revenue): Year Ended December 31, 2021 2020 2019 Largest collaboration partner 49 % 62 % 0 % Second largest collaboration partner 24 % 36 % 0 % Third largest collaboration partner 19 % 2 % 0 % |
Summary of balances and activities in our contract asset account | The following table summarizes balances and activities in our contract asset account (in thousands): Balance at Additions (1) Subtractions Balance Year ended December 31, 2021: Contract asset $ - $ 62,525 $ - $ 62,525 Year ended December 31, 2020: Contract asset $ - $ - $ - $ - (1) Additions are revenues recognized for CpG 1018 adjuvant transferred to Clover that is reserved under the CEPI Agreement. |
Summary of Deferred Revenue | The following table summarizes balances and activities in our deferred revenue accounts (in thousands): Balance at Additions (1) Subtractions (2) Revenue recognized in the current period included in deferred revenue balance at the beginning of the period Balance Year ended December 31, 2021: Deferred revenue $ 38,212 $ 371,860 $ ( 21,996 ) $ ( 38,212 ) $ 349,864 Long-term deferred revenue - 168,467 ( 163,082 ) - 5,385 Year ended December 31, 2020: Deferred revenue $ - $ 38,212 $ - $ - $ 38,212 Long-term deferred revenue - - - - - (1) Additions are primarily payments received or invoices issued before we satisfy our performance obligations. Subtractions are primarily revenues recognized in the period and reclassification from long-term deferred revenue to CEPI accrual. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | Year Ended December 31, 2021 2020 2019 Numerator Net income (loss) $ 76,713 $ ( 75,240 ) $ ( 152,600 ) Less: undistributed earnings allocated to participating securities ( 4,569 ) - - Less: preferred stock deemed dividend - - ( 3,267 ) Net income (loss) allocable to common stockholders, basic 72,144 ( 75,240 ) ( 155,867 ) Add: undistributed earnings allocated to Series B and warrants 4,569 - - Less: undistributed earnings allocated to Series B and warrants ( 4,190 ) - - Add: interest expense on convertible notes 3,168 - - Less: removal of change in fair value of warrant liability - ( 4,124 ) - Net income (loss) allocable to common stockholders, diluted $ 75,691 $ ( 79,364 ) $ ( 155,867 ) Denominator Weighted average shares used to compute net income (loss) allocable to 116,264 100,753 72,024 Effect of dilutive shares: Stock-based compensation plans 3,075 - - Convertible Notes (as converted to common stock) 13,667 - - Effect of dilutive warrants - 751 - Weighted average shares used to compute net income (loss) allocable to 133,006 101,504 72,024 |
Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share | December 31, 2021 2020 2019 Outstanding securities not included in diluted net income (loss) allocable to Stock options and stock awards 5,953 10,299 9,789 Series B Convertible Preferred Stock (as converted to common stock) - 4,140 4,840 Warrants (as exercisable into common stock) 1,883 - 5,841 Convertible Notes (as converted to common stock) - - - |
Common Stock (Tables)
Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Summary of Common Stock Warrants Outstanding | As of December 31, 2021, the following common stock warrants were outstanding: Warrants Issuance Date Shares Issuable Expiration Date Exercise Price Outstanding as of August 12, 2019 1,883 February 12, 2022 $ 4.50 1,883 |
Equity Plans and Stock-Based _2
Equity Plans and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Option Activity under Stock-Based Compensation Plans | Activity under our stock plans is set forth below: Shares Underlying Weighted-Average Exercise Weighted-Average Aggregate Balance at December 31, 2020 8,505 $ 11.57 Options granted 3,894 10.49 Options exercised ( 1,035 ) 6.46 Options cancelled: Options forfeited (unvested) ( 521 ) 8.13 Options expired (vested) ( 444 ) 18.48 Balance at December 31, 2021 10,399 $ 11.55 4.16 $ 42,756 Vested and expected to vest at 10,029 $ 11.57 4.08 $ 41,321 Exercisable at December 31, 2021 5,796 $ 13.07 2.64 $ 20,488 |
Summary of Non-vested Restricted Stock Units Activity | Our non-vested stock awards are comprised of restricted stock units granted with performance and time-based vesting criteria. A summary of the status of non-vested restricted stock units as of December 31, 2021, and activities during 2021 are summarized as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2020 1,794 $ 7.23 Granted 1,818 9.50 Vested ( 537 ) 8.85 Forfeited ( 424 ) 8.21 Non-vested as of December 31, 2021 2,651 $ 8.30 |
Summary Of Performance Based Restricted Stock Unit | We granted performance-based restricted stock unit (“PSU”) to certain executives in February 2021. These PSUs vest upon a specified market condition. The summary of PSU activities for the year ended December 31, 2021 is as follows: Number of Shares Weighted-Average Non-vested as of December 31, 2020 - $ - Granted 297 8.40 Forfeited ( 60 ) 8.40 Non-vested as of December 31, 2021 237 $ 8.40 |
Fair Value-Based Measurements and Weighted-Average Assumptions | The fair value of each option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value of each RSU is determined at the date of grant using our closing stock price. The fair value of each PSU is estimated using the Monte Carlo simulation method on the date of grant. The weighted-average assumptions used in the calculations of these fair value measurements are as follows: Stock Options Market-Based Performance Stock Unit (“PSUs”) Employee Stock Purchase Plan Year Ended December 31, Year Ended December 31, Year Ended December 31, 2021 2020 2019 2021 2021 2020 2019 Weighted-average fair value $ 7.17 $ 3.91 $ 4.58 $ 8.40 $ 6.48 $ 2.82 $ 2.72 Risk-free interest rate 0.7 % 1.0 % 2.1 % From 0.03 % to 1.92 % 0.1 % 0.9 % 1.9 % Expected life (in years) 4.5 4.5 4.5 2.9 1.2 1.2 1.2 Expected Volatility 0.9 0.9 0.9 0.9 1.0 0.7 0.7 |
Stock-Based Compensation Expense | We recognized the following amounts of stock-based compensation expense (in thousands): Year Ended December 31, 2021 2020 2019 Employees and directors stock-based compensation expense $ 21,285 $ 13,484 $ 25,456 Year Ended December 31, 2021 2020 2019 Research and development $ 3,818 $ 1,000 $ 8,058 Selling, general and administrative 14,894 9,585 10,224 Cost of sales - product 553 619 1,088 Inventory 2,020 2,280 1,964 Restructuring - - 4,122 Total $ 21,285 $ 13,484 $ 25,456 |
Restructuring (Tables)
Restructuring (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Major Components of Restructuring Costs | The major components of our restructuring costs are summarized as follows (in thousands): Components of Restructuring Costs Restructuring Costs Severance and other termination benefits $ 6,277 Stock-based compensation expense (a) 4,122 Accelerated depreciation 2,957 Total restructuring cost $ 13,356 (a) As a result of accelerated vesting of stock awards and the extension of exercise period of stock options |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Component of Consolidated (Loss) Income Before Provision for Income Taxes | Consolidated income (loss) before provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2021 2020 2019 U.S. $ 75,954 $ ( 76,324 ) $ ( 154,605 ) Non U.S. 1,567 1,084 2,005 Total $ 77,521 $ ( 75,240 ) $ ( 152,600 ) |
Difference Between Consolidated Income Tax Benefit and Amount Computed by Federal Statutory Income Tax Rate | Year Ended December 31, 2021 2020 2019 Income tax provision (benefit) at federal statutory rate $ 16,397 $ ( 15,756 ) $ ( 32,046 ) State tax 3,576 ( 3,194 ) ( 3,153 ) Business credits ( 982 ) ( 773 ) ( 1,757 ) Uncertain tax positions 424 193 5,426 Deferred compensation charges 131 809 4,600 Change in valuation allowance ( 86,847 ) 19,009 22,715 Section 162(m) limitation 1,241 473 2,439 Mark-to-market of warrants 10,364 ( 866 ) 1,575 Net operating loss and tax credit limitation 56,459 - - Other 45 105 201 Total income tax expense $ 808 $ - $ - |
Component of Deferred Tax Assets and Liabilities | Deferred tax assets and liabilities consisted of the following (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 155,503 $ 224,161 Research credit carryforwards 12,870 28,578 Lease liability 8,515 - Stock compensation 5,798 - Accruals and reserves 5,792 17,264 Other 212 3,250 Total deferred tax assets 188,690 273,253 Less valuation allowance ( 179,253 ) ( 266,100 ) Net deferred tax assets 9,437 7,153 Deferred tax liabilities: Fixed assets ( 3,283 ) ( 275 ) Operating lease right-of-use assets ( 6,124 ) ( 6,878 ) Other ( 30 ) - Total deferred tax liabilities ( 9,437 ) ( 7,153 ) Net deferred tax assets $ - $ - |
Schedule of Unrecognized Tax Benefits | The following table summarizes the activity related to our unrecognized tax benefits: Balance at December 31, 2020 $ ( 10,565 ) Tax positions related to the current year Additions ( 308 ) Reductions - Tax positions related to the prior year Additions - Reductions 5,258 Settlements - Lapses in statute - Balance at December 31, 2021 $ ( 5,615 ) |
Organization - Additional Infor
Organization - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2021 | |
HEPLISAV-B | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |
Minimum age approved for vaccine prevention of infection caused | 18 years |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019USD ($) | Dec. 31, 2021USD ($)Segment | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2017USD ($) | May 31, 2021USD ($) | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Number of operating segment | Segment | 1 | |||||
Cash, cash equivalents and marketable securities | $ 546,000,000 | |||||
Principal amount | 225,500,000 | $ 225,500,000 | ||||
Debt interest rate | 2.50% | |||||
Repayments of debt | 190,200,000 | |||||
Net Proceeds to Pay the Costs | 27,200,000 | |||||
Long-term debt, net of debt discount | $ 5,010,000 | $ 1,094,000 | ||||
Debt maturity date | May 15, 2026 | |||||
Net income (loss) | $ 76,713,000 | (75,240,000) | $ (152,600,000) | |||
Foreign Currency Transaction Gain (Loss), Unrealized | 2,500,000 | 2,700,000 | 500,000 | |||
Currency transaction gain (loss) | $ 900,000 | $ 800,000 | 200,000 | |||
Percentage of long lived assets | 43.00% | 57.00% | ||||
Inventory reserves | $ 0 | $ 0 | ||||
Inventory write-off | 2,588,000 | |||||
Accelerated depreciation related to certain long-lived assets | $ 3,000,000 | 0 | 0 | 3,000,000 | ||
Goodwill impairment | $ 0 | 0 | $ 0 | |||
Increase in product revenue | $ 800,000 | |||||
Product | Credit Concentration Risk | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Concentration risk, customer | one | one | ||||
Product | Trade Receivable | Customer Concentration Risk [Member] | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Concentration risk, percentage | 94.00% | 100.00% | ||||
HEPLISAV-B | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Net income (loss) | $ 76,700,000 | |||||
Inventory write-off | $ 0 | $ 0 | ||||
HEPLISAV-B | Credit Concentration Risk | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Concentration risk, customer | three | three | ||||
HEPLISAV-B | Trade Receivable | Credit Concentration Risk | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Concentration risk, percentage | 76.00% | 86.00% | ||||
Maximum | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Cash equivalents original maturity period | 3 months | |||||
Expected period of payment to be received | 1 year | |||||
Dynavax GmbH | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Cumulative translation adjustment | $ 2,300,000 | $ 200,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | ||
Transfers from level 1 to level 2 | $ 0 | $ 0 |
Transfers from level 2 to level 1 | 0 | 0 |
Transfers in or out of Level 3 | $ 0 | $ 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets | ||
Total assets | $ 538,955 | $ 157,091 |
Money Market Funds | ||
Assets | ||
Total assets | 429,194 | 23,128 |
U.S. Treasuries | ||
Assets | ||
Total assets | 4,004 | 32,579 |
U.S. Government Agency Securities | ||
Assets | ||
Total assets | 26,548 | 40,321 |
Corporate Debt Securities | ||
Assets | ||
Total assets | 79,209 | 61,063 |
Warrants | ||
Liabilities | ||
Total liabilities | 18,016 | 10,736 |
Fair Value, Inputs, Level 1 | ||
Assets | ||
Total assets | 429,194 | 23,128 |
Fair Value, Inputs, Level 1 | Money Market Funds | ||
Assets | ||
Total assets | 429,194 | 23,128 |
Fair Value, Inputs, Level 1 | U.S. Treasuries | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | Corporate Debt Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 1 | Warrants | ||
Liabilities | ||
Total liabilities | 0 | 0 |
Fair Value, Inputs, Level 2 | ||
Assets | ||
Total assets | 109,761 | 133,963 |
Fair Value, Inputs, Level 2 | Money Market Funds | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 2 | U.S. Treasuries | ||
Assets | ||
Total assets | 4,004 | 32,579 |
Fair Value, Inputs, Level 2 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 26,548 | 40,321 |
Fair Value, Inputs, Level 2 | Corporate Debt Securities | ||
Assets | ||
Total assets | 79,209 | 61,063 |
Fair Value, Inputs, Level 2 | Warrants | ||
Liabilities | ||
Total liabilities | 0 | 0 |
Fair Value, Inputs, Level 3 | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Money Market Funds | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. Treasuries | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | U.S. Government Agency Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Corporate Debt Securities | ||
Assets | ||
Total assets | 0 | 0 |
Fair Value, Inputs, Level 3 | Warrants | ||
Liabilities | ||
Total liabilities | $ 18,016 | $ 10,736 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assumptions to Estimate the Fair Value of Warrant Liability (Detail) shares in Thousands | Dec. 31, 2021shares | Dec. 31, 2020shares |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Number of shares | 0 | |
Fair Value, Inputs, Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Number of shares | 1,882,600 | |
Expected term | 1 month 6 days | |
Expected volatility | 0.7 | |
Risk-free interest rate | 0.001 | |
Dividend yield | 0 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Changes in Fair Value Warrant liability (Detail) - Fair Value, Inputs, Level 3 - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Beginning Balance | $ 10,736 | $ 14,860 |
Decrease in fair value of warrants exercised | (4,765) | |
Warrants exercised | (42,074) | |
Increase in the estimated fair value of warrant liability upon revaluation | 54,119 | (4,124) |
Ending Balance | $ 18,016 | $ 10,736 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 436,189 | $ 32,073 | $ 39,884 | |
Restricted cash | 219 | 237 | 216 | |
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows | $ 436,408 | $ 32,310 | $ 40,100 | $ 49,967 |
Cash, Cash Equivalents, Restr_4
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | $ 436,189 | $ 32,073 |
Unrealized Gains | ||
Unrealized Losses | ||
Estimated Fair Value | 436,189 | 32,073 |
Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 109,760 | 132,932 |
Unrealized Gains | 9 | 48 |
Unrealized Losses | (8) | (17) |
Estimated Fair Value | 109,761 | 132,963 |
Marketable Securities Available-for-Sale | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 545,949 | 165,005 |
Unrealized Gains | 9 | 48 |
Unrealized Losses | (8) | (17) |
Estimated Fair Value | 545,950 | 165,036 |
Cash | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 6,995 | 7,945 |
Unrealized Gains | ||
Unrealized Losses | ||
Estimated Fair Value | 6,995 | 7,945 |
Money Market Funds | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 429,194 | 23,128 |
Unrealized Gains | ||
Unrealized Losses | ||
Estimated Fair Value | 429,194 | 23,128 |
Corporate Debt Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 1,000 | |
Unrealized Gains | ||
Unrealized Losses | ||
Estimated Fair Value | 1,000 | |
Corporate Debt Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 79,200 | 60,071 |
Unrealized Gains | 9 | 3 |
Unrealized Losses | (11) | |
Estimated Fair Value | 79,209 | 60,063 |
U.S. Treasuries | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 4,005 | 32,548 |
Unrealized Gains | 31 | |
Unrealized Losses | (1) | |
Estimated Fair Value | 4,004 | 32,579 |
U.S. Government Agency Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 26,555 | 40,313 |
Unrealized Gains | 14 | |
Unrealized Losses | (7) | (6) |
Estimated Fair Value | $ 26,548 | $ 40,321 |
Cash, Cash Equivalents, Restr_5
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Maturities of Marketable Securities Available-for-Sale (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Amortized Cost | |
Mature in one year or less | $ 109,760 |
Mature after one year through two years | 0 |
Total amortized cost | 109,760 |
Estimated Fair Value | |
Mature in one year or less | 109,761 |
Mature after one year through two years | 0 |
Total estimated fair value | $ 109,761 |
Cash, Cash Equivalents, Restr_6
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |||
Realized gains on investments | $ 0 | $ 100 | $ 0 |
Realized loss on investments | $ 0 | $ 0 | $ 0 |
Inventories, Net - Summary of I
Inventories, Net - Summary of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 26,637 | $ 25,121 |
Work-in-process | 14,748 | 30,293 |
Finished goods | 19,950 | 8,275 |
Total | $ 61,335 | $ 63,689 |
Inventories, Net - Additional I
Inventories, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory [Line Items] | |||
Finished goods | $ 19,950 | $ 8,275 | |
Prepaid manufacturing | 159,655 | 29,423 | |
CpG 1018 Adjuvant Inventory | |||
Inventory [Line Items] | |||
Balance within raw materials and work-in-process inventory | 0 | 0 | |
Inventory write-offs recognized | 2,600 | 0 | $ 0 |
Prepaid manufacturing | 159,700 | 29,400 | |
HEPLISAV-B | |||
Inventory [Line Items] | |||
Finished goods | $ 18,600 | $ 8,300 |
Intangible Assets, Net - Additi
Intangible Assets, Net - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Aug. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Finite Lived Intangible Assets [Line Items] | |||||
Cost of sales - amortization of intangible assets | $ 0 | $ 2,500 | $ 9,217 | ||
Selling, general and administrative | $ 100,156 | 79,256 | $ 74,986 | ||
Asset Purchase Agreement | |||||
Finite Lived Intangible Assets [Line Items] | |||||
Upfront payment | 5,000 | ||||
Upfront payment receivable | 4,000 | ||||
Additional milestone payments receivable | $ 250,000 | ||||
Selling, general and administrative | $ 500 | $ 2,500 |
Property and Equipment, Net - C
Property and Equipment, Net - Component of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Line Items] | ||
Manufacturing equipment | $ 12,532 | $ 13,884 |
Lab equipment | 2,492 | 2,888 |
Computer equipment | 5,336 | 5,255 |
Furniture and fixtures | 2,463 | 2,510 |
Leasehold improvements | 27,634 | 28,417 |
Assets in progress | 9,941 | 1,024 |
Property, Plant and Equipment, Gross | 60,398 | 53,978 |
Less accumulated depreciation and amortization | (25,378) | (23,411) |
Total | $ 35,020 | $ 30,567 |
Manufacturing Equipment | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 5 years | |
Manufacturing Equipment | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 13 years | 14 years |
Lab Equipment | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 5 years | |
Lab Equipment | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 13 years | 13 years |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 3 years | 3 years |
Furniture and Fixtures | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 3 years | |
Furniture and Fixtures | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 13 years | 13 years |
Leasehold Improvements | Minimum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 2 years | |
Leasehold Improvements | Maximum | ||
Property Plant And Equipment [Line Items] | ||
Estimated Useful Lives (In years) | 10 years | 12 years |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation and amortization | $ 4,296,000 | $ 4,273,000 | $ 8,938,000 | |
Accelerated depreciation charges | $ 3,000,000 | $ 0 | $ 0 | $ 3,000,000 |
Current Accrued Liabilities a_3
Current Accrued Liabilities and Accrued Research and Development - Component of Current Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Liabilities Abstract | ||
Payroll and related expenses | $ 13,011 | $ 8,684 |
Revenue reserve accruals | 8,253 | 6,040 |
Accrued inventory | 20,868 | 338 |
Other accrued liabilities | 7,664 | 4,037 |
Total | $ 49,796 | $ 19,099 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions | Sep. 17, 2018USD ($)ft² | Sep. 30, 2021USD ($) | Aug. 31, 2020USD ($) | Jul. 31, 2019USD ($)ft² | Nov. 30, 2009USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2021EUR (€) | May 31, 2021USD ($) | Dec. 31, 2020EUR (€) | Mar. 29, 2019USD ($) | Feb. 20, 2018USD ($) | Dec. 31, 2004EUR (€) |
Loss Contingencies [Line Items] | ||||||||||||||
Tenant improvement allowance | $ 1,137,000 | $ 6,999,000 | ||||||||||||
Sublease income | 7,735,000 | 7,706,000 | 2,619,000 | |||||||||||
Cash paid for amounts included in the measurement of operating lease liabilities | 7,000,000 | 6,900,000 | ||||||||||||
Principal amount | $ 225,500,000 | $ 225,500,000 | ||||||||||||
Debt maturity date | May 15, 2026 | |||||||||||||
Non-cancelable purchase and other commitments | $ 98,726,000 | |||||||||||||
Liability under agreement | $ 816,872,000 | 294,579,000 | ||||||||||||
Incremental borrowing rate | 10.10% | |||||||||||||
Long-term debt, net of debt discount | $ 5,010,000 | 1,094,000 | ||||||||||||
Gain on sale of assets | 1,000,000 | 6,851,000 | 0 | |||||||||||
Selling, general and administrative | 100,156,000 | 79,256,000 | 74,986,000 | |||||||||||
2.50% Convertible Senior Notes Due 2026 | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Principal amount | $ 225,500,000 | |||||||||||||
Debt maturity date | May 15, 2026 | |||||||||||||
Long-term debt, net of debt discount | $ 5,000,000 | |||||||||||||
Asset Purchase Agreement | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Upfront payment | 5,000,000 | |||||||||||||
Upfront payment receivable | 4,000,000 | |||||||||||||
Additional milestone payments receivable | 250,000,000 | |||||||||||||
Gain on sale of assets | $ 1,000,000 | 6,900,000 | ||||||||||||
Selling, general and administrative | $ 500,000 | $ 2,500,000 | ||||||||||||
Symphony Dynamo Holdings Llc | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
License arrangement contingent consideration percentage | 50.00% | |||||||||||||
License arrangement upfront payment | $ 50,000,000 | |||||||||||||
Trisalus Life Sciences | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Payment Received For Pre Commercialization Milestone | $ 1,000,000 | |||||||||||||
Deutsche Bank Securities | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Letter of credit pledged as security | € | € 0.2 | |||||||||||||
Collateralized certificate of deposit | € | € 0.2 | € 0.2 | ||||||||||||
CRG Servicing LLC | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Maximum borrowing capacity | $ 175,000,000 | |||||||||||||
Current borrowing capacity | $ 75,000,000 | $ 100,000,000 | ||||||||||||
Debt maturity date | Dec. 31, 2023 | |||||||||||||
Emeryville, California (Premises) | Horton Street Sublease | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Lease area | ft² | 75,662 | 75,662 | ||||||||||||
Base rent per square feet | $ 4,750 | $ 5,500 | ||||||||||||
Lease expiration date | Mar. 31, 2031 | |||||||||||||
Option to extend | The Subtenant has no option to extend the sublease term. | |||||||||||||
Existence of option to extend | false | |||||||||||||
Operations commencement date | Apr. 1, 2019 | |||||||||||||
Tenant improvement allowance | $ 8,100,000 | |||||||||||||
Initial lease term | 12 years | |||||||||||||
Lease option to extend | The Horton Street Master Lease has an initial term of 12 years, following the Commencement Date with an option to extend the lease for two successive five-year terms | |||||||||||||
Renewal term of lease | 5 years | |||||||||||||
Emeryville, California (Premises) | Horton Street Sublease | Other Nonoperating Income (Expense) | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Sublease income | $ 7,700,000 | $ 7,700,000 | $ 2,600,000 | |||||||||||
Powell Street Sublease | Emeryville, California (Premises) | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Lease area | ft² | 23,976 | |||||||||||||
Base rent per square feet | $ 3.90 | |||||||||||||
Lease expiration date | Jun. 30, 2022 | |||||||||||||
Option to extend | There is no option to extend the sublease term. | |||||||||||||
Existence of option to extend | false | |||||||||||||
Horton Street Master Lease | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Percentage of excess rent paid to landlord | 50.00% | 50.00% | ||||||||||||
New Dusseldorf Lease | Germany | ||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||
Operations commencement date | Jan. 1, 2022 | |||||||||||||
Initial lease term | 10 years | |||||||||||||
Lease option to extend | The New Düsseldorf Lease has an initial term of 10 years, beginning on January 1, 2022, with an option to extend the lease for two successive five-year terms. | |||||||||||||
Renewal term of lease | 5 years |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Operating Lease Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease expense | $ 6,265 | $ 6,267 | $ 6,886 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Balance Sheet Classification of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
Current portion of lease liabilities (included in other current liabilities) | $ 2,577 | $ 3,247 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherCurrentLiabilitiesMember | us-gaap:OtherCurrentLiabilitiesMember |
Long-term portion of lease liabilities | $ 34,316 | $ 34,789 |
Total operating lease liabilities | $ 36,893 | $ 38,036 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Maturities of Sublease Income and Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Sublease Income | ||
2022 | $ 5,357 | |
2023 | 5,518 | |
2024 | 5,684 | |
2025 | 5,854 | |
2026 | 6,030 | |
Thereafter | 27,712 | |
Total | 56,155 | |
Operating Lease Liabilities | ||
2022 | 6,174 | |
2023 | 5,634 | |
2024 | 5,778 | |
2025 | 5,927 | |
2026 | 6,080 | |
Thereafter | 28,259 | |
Total | 57,852 | |
Present value adjustment | (20,959) | |
Total | $ 36,893 | $ 38,036 |
Commitments and Contingencies_5
Commitments and Contingencies - Summary of Weighted Average Remaining Lease Term and Weighted Average Discount Rate (Detail) | Dec. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term | 9 years 1 month 6 days | 9 years 1 month 6 days |
Weighted average discount rate | 10.10% | 10.10% |
Commitments and Contingencies_6
Commitments and Contingencies - Schedule of Material Purchase Commitments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 | $ 55,318 |
2023 | 9,312 |
2024 | 10,857 |
2025 | 11,367 |
2026 | 11,872 |
Thereafter | 0 |
Total | $ 98,726 |
Collaborative Research, Devel_2
Collaborative Research, Development and License Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 31, 2021 | May 31, 2021 | Jan. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | $ 439,442 | $ 46,551 | $ 35,219 | ||||
Deferred revenue | 55,400 | ||||||
Coalition for Epidemic Preparedness Innovations | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Interest- free unsecured forgivable loan | $ 99,000 | ||||||
Advance payment from customer | 168,500 | ||||||
Accounts receivable | $ 0 | 14,600 | 0 | ||||
CEPI accrual | 128,800 | 0 | |||||
Valneva SE | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Advance payment from customer | $ 55,400 | ||||||
Consideration Allocated To The Remaining Performance Obligation | $ 55,400 | ||||||
U.S. Department of Defense | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | 500 | ||||||
Proceeds from grant | 22,000 | ||||||
Serum Institute of India Pvt. Ltd. | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | 400 | 900 | 100 | ||||
Other Long Term Liabilities | Coalition for Epidemic Preparedness Innovations | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Advance payment from customer | 5,400 | ||||||
Reservation Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Interest- free unsecured forgivable loan | $ 77,400 | ||||||
Reservation Agreement | Coalition for Epidemic Preparedness Innovations | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | 6,300 | ||||||
Interest- free unsecured forgivable loan | $ 176,400 | ||||||
Reservation fees | 6,300 | ||||||
Supply Agreement | Clover | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | 72,200 | 0 | 0 | ||||
Deferred revenue | 0 | 191,100 | 0 | ||||
Contract asset balance | 0 | 62,500 | 0 | ||||
Accounts receivable | 0 | 2,100 | 0 | ||||
Supply Agreement | Biological E. Limited | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | 185,700 | 0 | 0 | ||||
Deferred revenue | 0 | 103,300 | 0 | ||||
Accounts receivable | 0 | 96,100 | 0 | ||||
Supply Agreement | Medigen | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | 26,700 | 1,200 | 0 | ||||
Accounts receivable | 0 | 2,400 | 0 | ||||
Supply Agreement | Valneva SE | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | 89,400 | 2,000 | $ 0 | ||||
Deferred revenue | $ 37,000 | 55,400 | $ 37,000 | ||||
Grant Agreement | Bill & Melinda Gates Foundation | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | 1,200 | ||||||
Deferred revenue | 1,200 | ||||||
Amount Spend On Grant-related Activity | 1,200 | ||||||
Grant Agreement | Bill & Melinda Gates Foundation | Maximum | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Proceeds from grant | $ 3,400 |
Convertible Notes (Additional I
Convertible Notes (Additional Information) (Details) | 1 Months Ended | 12 Months Ended | ||
May 31, 2021USD ($) | Dec. 31, 2021USD ($)d$ / sharesshares | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Debt Instrument [Line Items] | ||||
Aggregate principal amount | $ 225,500,000 | $ 225,500,000 | ||
Debt interest rate | 2.50% | |||
Proceeds from issuance of Convertible Notes, net | 219,822,000 | |||
Repayments of debt | 190,200,000 | |||
Net Proceeds to Pay the Costs | $ 27,200,000 | |||
Debt maturity date | May 15, 2026 | |||
Fair value of the convertible notes | $ 368,600,000 | |||
Notes | ||||
Debt Instrument [Line Items] | ||||
Aggregate principal amount | $ 200,000,000 | |||
2.50% Convertible Senior Notes Due 2026 | ||||
Debt Instrument [Line Items] | ||||
Aggregate principal amount | 225,500,000 | |||
Debt interest rate | 2.50% | |||
Debt issuance and offering costs | $ 5,700,000 | $ 5,000,000 | ||
Proceeds from issuance of Convertible Notes, net | 219,800,000 | |||
Debt instrument, interest rate terms | The Convertible Notes are general unsecured obligations and accrue interest at a rate of 2.50% per annum payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021 | |||
Debt maturity date | May 15, 2026 | |||
Initial conversion rate | 95.5338 | |||
Debt conversion, original debt, principal amount converted | $ 1,000 | |||
Debt instrument, conversion price per share | $ / shares | $ 10.47 | |||
Debt instrument, convertible, threshold trading days | d | 20 | |||
Debt instrument, convertible, threshold consecutive trading days | d | 30 | |||
Debt instrument, convertible, threshold percentage of stock price trigger | 130.00% | |||
Debt Instrument, redemption, description | We may redeem for cash all or any portion of the Convertible Notes, at our option, on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100% of the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. | |||
Debt instrument, redemption earliest date | May 20, 2024 | |||
Percentage of principal redeemed | 100.00% | |||
Debt instrument interest rate, effective percentage | 3.10% | |||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period One | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, convertible, threshold trading days | d | 20 | |||
Debt instrument, convertible, threshold consecutive trading days | d | 30 | |||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period One | Maximum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, convertible, threshold percentage of stock price trigger | 130.00% | |||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period Two | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, convertible, threshold trading days | d | 5 | |||
Debt instrument, convertible, threshold consecutive trading days | d | 10 | |||
2.50% Convertible Senior Notes Due 2026 | Debt Instrument, Conversion, Period Two | Maximum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, convertible, threshold percentage of stock price trigger | 98.00% | |||
Optional Notes | ||||
Debt Instrument [Line Items] | ||||
Additional issue amount | 25,500,000 | |||
Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Repayments of debt | 190,200,000 | |||
Capped Calls | ||||
Debt Instrument [Line Items] | ||||
Net Proceeds to Pay the Costs | $ 27,200,000 | $ 27,200,000 | ||
Number of shares converted | shares | 21,542,871 | |||
Initial strike price | $ / shares | $ 10.47 | |||
Initial cap price | $ / shares | $ 15.80 | |||
Reduction to additional paid-in capital, capped calls cost | $ 27,200,000 |
Convertible Notes - Summary of
Convertible Notes - Summary of Interest Expenses Related to Convertible Notes (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Debt Disclosure [Abstract] | |
Stated coupon interest | $ 3,555 |
Amortization of debt issuance cost | 669 |
Total interest expense | $ 4,224 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - USD ($) $ in Thousands | Feb. 20, 2018 | Jun. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | May 31, 2021 | Mar. 29, 2019 |
Debt Instrument [Line Items] | ||||||||
Net proceeds from the initial term loan | $ 74,250 | |||||||
Debt interest rate | 2.50% | |||||||
Long-term debt, net of debt discount | $ 5,010 | 1,094 | ||||||
Debt maturity date | May 15, 2026 | |||||||
Interest expense related to initial term loan | $ 4,224 | |||||||
Loss on debt extinguishment | (5,232) | 0 | 0 | |||||
Repayment of long-term debt | 190,194 | |||||||
Loan Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest expense related to initial term loan | $ 7,000 | $ 19,100 | $ 16,500 | |||||
CRG Servicing LLC | ||||||||
Debt Instrument [Line Items] | ||||||||
Maximum borrowing capacity | $ 175,000 | |||||||
Net proceeds from the initial term loan | $ 173,300 | |||||||
Debt interest rate | 9.50% | |||||||
Debt maturity date | Dec. 31, 2023 | |||||||
Current borrowing capacity | $ 100,000 | $ 75,000 | ||||||
Loss on debt extinguishment | $ 5,200 | |||||||
Repayment of long-term debt | $ 190,200 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Disaggregation of Revenues (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 439,442 | $ 46,551 | $ 35,219 |
UNITED STATES | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 63,785 | 36,030 | 35,054 |
Non-US [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 375,657 | 10,521 | 165 |
Other Revenue | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 2,343 | 7,244 | 575 |
Other Revenue | UNITED STATES | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 1,915 | 410 | |
Other Revenue | Non-US [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 428 | 7,244 | 165 |
HEPLISAV-B | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 61,870 | 36,030 | 34,644 |
HEPLISAV-B | UNITED STATES | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 61,870 | 36,030 | 34,644 |
HEPLISAV-B | Non-US [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | |||
CpG 1018 | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 375,229 | 3,277 | |
CpG 1018 | UNITED STATES | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | |||
CpG 1018 | Non-US [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 375,229 | 3,277 | |
Product | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 437,099 | 39,307 | 34,644 |
Product | UNITED STATES | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | 61,870 | 36,030 | 34,644 |
Product | Non-US [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Total revenues | $ 375,229 | $ 3,277 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Revenues from Major Customers (Details) - Revenue Benchmark [Member] - Product Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Largest Customer | HEPLISAV-B | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 21.00% | 21.00% | 22.00% |
Second Largest Customer | HEPLISAV-B | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 19.00% | 20.00% | 21.00% |
Third Largest Customer | HEPLISAV-B | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 19.00% | 20.00% | 19.00% |
Largest Collaboration Partner | CpG 1018 | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 49.00% | 62.00% | 0.00% |
Second Largest Collaboration Partner | CpG 1018 | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 24.00% | 36.00% | 0.00% |
Third Largest Customer | CpG 1018 | |||
Concentration Risk [Line Items] | |||
Percentage of product revenue | 19.00% | 2.00% | 0.00% |
Revenue Recognition - Summary_2
Revenue Recognition - Summary of Product Revenue Allowance and Reserve Categories (Detail) - HEPLISAV-B - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounts Receivable Reserves | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | $ 2,836 | $ 2,701 |
Provisions related to current period sales | 18,209 | 11,417 |
Credit or payments made during the period | (17,222) | (11,282) |
Balance at End of Period | 3,823 | 2,836 |
Revenue Reserve Accruals | ||
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | 6,040 | 3,893 |
Provisions related to current period sales | 13,077 | 6,694 |
Credit or payments made during the period | (10,864) | (4,547) |
Balance at End of Period | $ 8,253 | $ 6,040 |
Revenue Recognition - Summary_3
Revenue Recognition - Summary of balances and activities in our contract asset account (Details) - Cp G1018 [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Contract Asset Account [Abstract] | ||
Balance at Beginning of Period | $ 0 | $ 0 |
Additions/(Subtractions) | 62,525 | |
Balance at End of Period | $ 62,525 | $ 0 |
Revenue Recognition - Summary_4
Revenue Recognition - Summary of Balances and Activities Deferred Revenue Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Deferred Revenue Arrangement [Line Items] | ||
Balance at Beginning of Period | $ 38,212 | |
Balance at End of Period | 349,864 | $ 38,212 |
CpG 1018 | ||
Deferred Revenue Arrangement [Line Items] | ||
Balance at Beginning of Period | 38,212 | |
Additions | 371,860 | 38,212 |
Subtractions | (21,996) | |
Revenue recognized in the current period included in deferred revenue balance at the beginning of the period | 38,212 | |
Balance at End of Period | 349,864 | 38,212 |
CpG 1018 | Long-term Deferred Revenue | ||
Deferred Revenue Arrangement [Line Items] | ||
Balance at Beginning of Period | ||
Additions | 168,467 | |
Subtractions | (163,082) | |
Revenue recognized in the current period included in deferred revenue balance at the beginning of the period | ||
Balance at End of Period | $ 5,385 |
Computation of Basic and Dilute
Computation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure Computation Of Basic And Diluted Earnings Per Share [Abstract] | |||
Net income (loss) | $ 76,713 | $ (75,240) | $ (152,600) |
Less: undistributed earnings allocated to participating securities | (4,569) | 0 | 0 |
Less: preferred stock deemed dividend | 0 | 0 | (3,267) |
Net income (loss) allocable to common stockholders, basic | 72,144 | (75,240) | (155,867) |
Add: undistributed earnings allocated to Series B and warrants | 4,569 | 0 | 0 |
Less: undistributed earnings allocated to Series B and warrants | (4,190) | 0 | 0 |
Add: interest expense on convertible notes | 3,168 | 0 | 0 |
Less: removal of change in fair value of warrant liability | 49,354 | (4,124) | 7,500 |
Net income (loss) allocable to common stockholders, diluted | $ 75,691 | $ (79,364) | $ (155,867) |
Weighted average shares used to compute basic net loss per share allocable to common stockholders | 116,264 | 100,753 | 72,024 |
Stock-based compensation expense | $ 3,075 | ||
Convertible Notes (as converted to common stock) | 13,667 | ||
Effect of dilutive warrants | 751 | ||
Weighted average shares used to compute net loss allocable to common stockholders per share, diluted | 133,006 | 101,504 | 72,024 |
Outstanding Stock Options and S
Outstanding Stock Options and Stock Awards Excluded from Calculation of Net Loss Per Share (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||
Outstanding securities not included in diluted net loss per share calculation | 13,667 | ||
Stock Options and Stock Awards | |||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||
Outstanding securities not included in diluted net loss per share calculation | 5,953 | 10,299 | 9,789 |
Warrants | |||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||
Outstanding securities not included in diluted net loss per share calculation | 1,883 | 0 | 5,841 |
Convertible Notes | |||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||
Outstanding securities not included in diluted net loss per share calculation | 0 | 0 | 0 |
Series B Convertible Preferred Stock | |||
Outstanding securities not included in diluted net loss per share calculation (in thousands): | |||
Outstanding securities not included in diluted net loss per share calculation | 0 | 4,140 | 4,840 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Feb. 28, 2022 | Aug. 06, 2020 | Aug. 31, 2021 | May 31, 2020 | Aug. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2021 | Nov. 03, 2017 |
Class Of Stock [Line Items] | ||||||||||
Common stock, shares outstanding | 122,945,357 | 110,190,000 | ||||||||
Issuance of common stock and preferred stock (in shares) | 18,525,000 | |||||||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||||||
Preferred stock, par value | $ 0.001 | |||||||||
Proceeds from issuances of common stock, net | $ 28,156 | $ 108,538 | $ 65,948 | |||||||
Preferred stock deemed dividend | $ 0 | $ 0 | $ 3,267 | |||||||
Number of common stock warrants exercised | 3,958,650,000 | 0 | ||||||||
Number of shares | 0 | |||||||||
Less: removal of change in fair value of warrant liability | $ 49,354 | $ (4,124) | $ 7,500 | |||||||
Subsequent Event | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Number of common stock warrants exercised | 1,882,600 | |||||||||
Cash Settlement | $ 8,500 | |||||||||
Common Stock | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Number of common stock allowed to purchase | 4,140,000 | |||||||||
Warrants | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Number of shares | 1,883,000 | |||||||||
Fair value of derivative liability | $ 18,000 | 10,700 | ||||||||
Warrants Called for purchase | 1,883,000 | |||||||||
Warrants | Other Nonoperating Income (Expense) | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Less: removal of change in fair value of warrant liability | $ 49,400 | $ 4,100 | $ 7,500 | |||||||
Bain Life Sciences | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Net cash proceeds received from issuance or sale of equity | $ 35,000 | |||||||||
Bain Life Sciences | Common Stock | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Warrants Called for purchase | 2,916,250,000 | |||||||||
Proceeds From Warrants Sale | 11,800,000 | |||||||||
Offering | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Issuance of common stock and preferred stock (in shares) | 2,100,000 | |||||||||
Common stock, par value | $ 0.001 | |||||||||
Price of common stock | $ 5 | |||||||||
Net cash proceeds received from issuance or sale of equity | $ 75,400 | $ 65,600 | ||||||||
Offering | Bain Capital Life Sciences Fund, L.P | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Issuance of common stock and preferred stock (in shares) | 1,000,000 | |||||||||
2017 ATM Agreement | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Issuance of common stock and preferred stock (in shares) | 2,878,567,000 | |||||||||
Proceeds from issuances of common stock, net | $ 28,200 | |||||||||
Remaining proceeds from common stock, under sales agreement | $ 120,500 | |||||||||
Series B Convertible Preferred Stock | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Issuance of common stock and preferred stock (in shares) | 4,140 | 4,840,000 | ||||||||
Preferred stock, par value | $ 0.001 | |||||||||
Preferred stock, shares outstanding | 0 | 4,000 | ||||||||
Maximum | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Common stock sales agreement aggregate sales proceeds | $ 150,000 | |||||||||
Maximum | Warrants | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Percentage of common stock held not to exceed for warrant exercises | 19.99% | |||||||||
Maximum | Offering | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Issuance of common stock and preferred stock (in shares) | 16,100,000 | |||||||||
Warrant issued | 5,841,250 | |||||||||
Maximum | 2017 ATM Agreement | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Commission on gross sales proceeds of common stock | 3.00% | |||||||||
Minimum | Warrants | ||||||||||
Class Of Stock [Line Items] | ||||||||||
Percentage of common stock to be held for exercise of warrants | 4.99% |
Common Stock - Summary of Commo
Common Stock - Summary of Common Stock Warrants Outstanding (Detail) - $ / shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Class Of Stock [Line Items] | ||
Number of shares | 0 | |
Warrants | ||
Class Of Stock [Line Items] | ||
Warrants Issuance Date | Aug. 12, 2019 | |
Shares Issuable | 1,883 | |
Expiration Date | Feb. 12, 2022 | |
Exercise Price per Share | $ 4.50 | |
Number of shares | 1,883 |
Equity Plans and Stock-Based _3
Equity Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) | May 31, 2018 | May 28, 2014 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | May 31, 2021 | Jan. 31, 2021 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Outstanding stock awards granted | 10,399,000 | 8,505,000 | |||||
Total intrinsic value of options exercised | $ 7,900,000 | $ 100,000 | $ 26,000 | ||||
Total fair value of stock options vested | 9,000,000 | 13,800,000 | 19,500,000 | ||||
Share-based Payment Arrangement, Noncash Expense | $ 21,285,000 | 13,484,000 | 25,456,000 | ||||
Expected dividend yield | 0.00% | ||||||
Stock-based compensation expense | $ 3,075,000 | ||||||
Increase in aggregate number of shares of common stock authorized for issuance | 1,000,000 | ||||||
Restructuring | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock-based compensation expense | 0 | 0 | 4,122,000 | ||||
Restricted Stock Units (RSUs) | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock based compensation expense related to restricted stock | 7,900,000 | ||||||
Aggregate intrinsic value | 37,300,000 | ||||||
Total fair value of restricted stock units | $ 4,700,000 | $ 4,900,000 | 7,900,000 | ||||
Restricted stock unit awards outstanding | 2,651,000 | 1,794,000 | |||||
Share vested | 537,000 | ||||||
Employee Stock Option | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Outstanding stock awards granted | 117,000 | ||||||
Performance Based Vesting Condition | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock based compensation expense related to restricted stock | $ 0 | $ 100,000 | $ 500,000 | ||||
Restricted stock unit awards outstanding | 202,050 | ||||||
Performance Based Restricted Stock Units | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock based compensation expense related to restricted stock | $ 1,800,000 | ||||||
Aggregate intrinsic value | $ 3,300,000 | ||||||
Restricted stock unit awards outstanding | 237,000 | ||||||
Share vested | 0 | ||||||
Maximum | Employee Stock Option | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Expiration period | 10 years | ||||||
Options vesting period | 3 years | ||||||
Minimum | Employee Stock Option | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Expiration period | 7 years | ||||||
Options vesting period | 4 years | ||||||
2018 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Expiration period | 7 years | ||||||
Shares reserved and approved for issuance | 4,851,391 | ||||||
Common Stock, Capital Shares Reserved for Future Issuance | 3,250,000 | 1,500,000 | |||||
Amended 2018 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares remaining available for future purchases | 22,517,869 | ||||||
Time Based Vesting Schedule | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Total unrecognized compensation cost related to non-vested equity awards | $ 33,000,000 | ||||||
Total unrecognized compensation cost, weighted-average vesting period | 2 years | ||||||
Time Based Vesting Schedule | Performance Based Restricted Stock Units | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Total unrecognized compensation cost related to non-vested equity awards | $ 200,000 | ||||||
Performance Based Vesting Schedule | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Total unrecognized compensation cost related to non-vested equity awards | 1,000,000 | ||||||
2014 Employee Stock Purchase Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Total unrecognized compensation cost related to non-vested equity awards | $ 1,100,000 | ||||||
Total unrecognized compensation cost, weighted-average vesting period | 1 year 6 months | ||||||
Shares issued to employees | 217,270 | ||||||
Shares remaining available for future purchases | 1,038,313 | ||||||
2014 Employee Stock Purchase Plan | The commencement of the offer period (generally, the sixteenth day in February or August) | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Purchase price per share as percentage of fair market value of common stock | 85.00% | ||||||
2014 Employee Stock Purchase Plan | The exercise date, which is the last day of a purchase period (generally, the fifteenth day in February or August) | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Purchase price per share as percentage of fair market value of common stock | 85.00% | ||||||
2014 Employee Stock Purchase Plan | Maximum | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares remaining available for future purchases | 1,850,000,000 |
Equity Plans and Stock-Based _4
Equity Plans and Stock-Based Compensation - Option Activity under Stock-Based Compensation Plans (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Shares Underlying Outstanding Options | |
Beginning balance | shares | 8,505 |
Options granted | shares | 3,894 |
Options exercised | shares | (1,035) |
Ending balance | shares | 10,399 |
Vested and expected to vest at December 31, 2021 | shares | 10,029 |
Exercisable at December 31, 2021 | shares | 5,796 |
Weighted-Average Exercise Price Per Share | |
Beginning balance | $ / shares | $ 11.57 |
Options granted | $ / shares | 10.49 |
Options exercised | $ / shares | 6.46 |
Ending balance | $ / shares | 11.55 |
Vested and expected to vest at December 31, 2021 | $ / shares | 11.57 |
Exercisable at December 31, 2021 | $ / shares | $ 13.07 |
Weighted-Average Remaining Contractual Term (years) | |
Balance at December 31, 2021 | 4 years 1 month 28 days |
Vested and expected to vest at December 31, 2021 | 4 years 29 days |
Exercisable at December 31, 2021 | 2 years 7 months 20 days |
Aggregate Intrinsic Value | |
Balance at December 31, 2021 | $ | $ 42,756 |
Vested and expected to vest at December 31, 2021 | $ | 41,321 |
Exercisable at December 31, 2021 | $ | $ 20,488 |
Unvested | |
Shares Underlying Outstanding Options | |
Options cancelled | shares | (521) |
Weighted-Average Exercise Price Per Share | |
Options cancelled | $ / shares | $ 8.13 |
Vested | |
Shares Underlying Outstanding Options | |
Options cancelled | shares | (444) |
Weighted-Average Exercise Price Per Share | |
Options cancelled | $ / shares | $ 18.48 |
Equity Plans and Stock-Based _5
Equity Plans and Stock-Based Compensation - Summary of Non-vested Restricted Stock Units Activity (Detail) - Restricted Stock Units (RSUs) shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Number of Shares | |
Non-vested, Beginning Balance | shares | 1,794 |
Granted | shares | 1,818 |
Vested | shares | (537) |
Forfeited | shares | (424) |
Non-vested, Ending Balance | shares | 2,651 |
Weighted-Average Grant-Date Fair Value Per Share | |
Non-vested, Beginning Balance | $ / shares | $ 7.23 |
Granted | $ / shares | 9.50 |
Vested | $ / shares | 8.85 |
Forfeited | $ / shares | 8.21 |
Non-vested, Ending Balance | $ / shares | $ 8.30 |
Equity Plans and Stock-Based _6
Equity Plans and Stock-Based Compensation - Summary Of Performance Based Restricted Stock Unit (Details) - Performance Based Restricted Stock Units shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Granted | shares | 297 |
Forfeited | shares | (60) |
Non-vested, Ending Balance | shares | 237 |
Granted | $ / shares | $ 8.40 |
Forfeited | $ / shares | 8.40 |
Non-vested, Ending Balance | $ / shares | $ 8.40 |
Equity Plans and Stock-Based _7
Equity Plans and Stock-Based Compensation - Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average fair value | $ 7.17 | $ 3.91 | $ 4.58 |
Risk-free interest rate | 0.70% | 1.00% | 2.10% |
Expected life (in years) | 4 years 6 months | 4 years 6 months | |
Expected Volatility | 0.90% | 0.90% | 0.90% |
Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average fair value | $ 6.48 | $ 2.82 | $ 2.72 |
Risk-free interest rate | 0.10% | 0.90% | 1.90% |
Expected life (in years) | 1 year 2 months 12 days | 1 year 2 months 12 days | 1 year 2 months 12 days |
Expected Volatility | 1.00% | 0.70% | 0.70% |
Market Based Performance Stock Unit | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average fair value | $ 8.40 | ||
Expected life (in years) | 2 years 10 months 24 days | ||
Expected Volatility | 0.90% | ||
Market Based Performance Stock Unit | Minimum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Risk-free interest rate | 0.03% | ||
Market Based Performance Stock Unit | Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Risk-free interest rate | 1.92% |
Equity Plans and Stock-Based _8
Equity Plans and Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Employees and directors stock-based compensation expense | $ 21,285 | $ 13,484 | $ 25,456 |
Stock-based compensation expense | 3,075 | ||
Inventory | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 2,020 | 2,280 | 1,964 |
Research and Development | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 3,818 | 1,000 | 8,058 |
Selling, General and Administrative | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 14,894 | 9,585 | 10,224 |
Cost of Sales - Product | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | 553 | 619 | 1,088 |
Restructuring | |||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | |||
Stock-based compensation expense | $ 0 | $ 0 | $ 4,122 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Pension and Other Postretirement Benefits Cost (Reversal of Cost) [Abstract] | |||
Contributions to 401 (k) plan | $ 0.3 | $ 0.2 | $ 0.3 |
Restructuring - Additional Info
Restructuring - Additional Information (Detail) - Position | May 23, 2019 | Dec. 31, 2020 |
Restructuring and Related Activities [Abstract] | ||
Number of positions reduced in global workforce | 80 | |
Percentage of reduction in global workforce | 36.00% | |
Restructuring completion date | Dec. 31, 2020 |
Restructuring - Schedule of Maj
Restructuring - Schedule of Major Components of Restructuring Costs (Detail) $ in Thousands | Dec. 31, 2019USD ($) | |
Restructuring Cost And Reserve [Line Items] | ||
Restructuring Costs Incurred for the Year Ended December 31, 2019 | $ 13,356 | |
Severance and Other Termination Benefits | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring Costs Incurred for the Year Ended December 31, 2019 | 6,277 | |
Stock-Based Compensation Expense | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring Costs Incurred for the Year Ended December 31, 2019 | 4,122 | [1] |
Accelerated Depreciation | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring Costs Incurred for the Year Ended December 31, 2019 | $ 2,957 | |
[1] | As a result of accelerated vesting of stock awards and the extension of exercise period of stock options |
Restructuring - Schedule of Com
Restructuring - Schedule of Components of the Restructuring Liabilities (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Restructuring Cost And Reserve [Line Items] | |||
Severance and other termination benefits | $ 0 | $ 0 | $ 13,356 |
Component of Consolidated (Loss
Component of Consolidated (Loss) Income Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ 75,954 | $ (76,324) | $ (154,605) |
Non U.S. | 1,567 | 1,084 | 2,005 |
Total | $ 77,521 | $ (75,240) | $ (152,600) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Line Items] | |||
Provision for income taxes | $ 808,000 | $ 0 | $ 0 |
Increase (decrease) in valuation allowance | 86,800,000 | 19,000,000 | |
Net operating loss carryforwards | 333,400,000 | ||
Unrecognized tax benefits | 5,615,000 | 10,565,000 | |
Unrecognized tax benefits would affect the effective tax rate | 0 | ||
Interest related to unrecognized tax benefits | 0 | $ 0 | |
Penalties related to unrecognized tax benefits | 200,000 | ||
Federal | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 303,800,000 | ||
Federal | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2022 | ||
Federal | Research And Development Tax Credits | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount | $ 1,900,000 | ||
Federal | Research And Development Tax Credits | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount, expiration year | 2022 | ||
Federal | Research And Development Tax Credits | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount, expiration year | 2041 | ||
California and Other States | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 345,900,000 | ||
California and Other States | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2022 | ||
California and Other States | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2041 | ||
California State | Research And Development Tax Credits | |||
Income Tax Disclosure [Line Items] | |||
Tax credit carryforward amount | $ 19,600,000 | ||
Foreign | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | $ 3,500,000 |
Income Taxes - Schedule of inco
Income Taxes - Schedule of income tax provision (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Income Tax Expense (Benefit) | $ 808,000 | $ 0 | $ 0 |
Deferred Income Tax Expense (Benefit), Continuing Operations [Abstract] | |||
Federal | 0 | ||
State | 0 | ||
Non-US | 0 | ||
Deferred Income Tax Expense (Benefit), Total | 0 | ||
Current Income Tax Expense (Benefit), Continuing Operations [Abstract] | |||
Federal | 345,000 | ||
State | 260,000 | ||
Non-US | 203,000 | ||
Current Income Tax Expense (Benefit), Total | $ 808,000 |
Difference between Consolidated
Difference between Consolidated Income Tax Benefit and Amount Computed by Federal Statutory Income Tax Rate (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit at federal statutory rate | $ 16,397,000 | $ (15,756,000) | $ (32,046,000) |
State tax | 3,576,000 | (3,194,000) | (3,153,000) |
Business credits | (982,000) | (773,000) | (1,757,000) |
Uncertain tax positions | 424,000 | 193,000 | 5,426,000 |
Deferred compensation charges | 131,000 | 809,000 | 4,600,000 |
Change in valuation allowance | (86,847,000) | 19,009,000 | 22,715,000 |
Section 162(m) limitation | 1,241,000 | 473,000 | 2,439,000 |
Mark-to-market of warrants | 10,364,000 | (866,000) | 1,575,000 |
Net operating loss and tax credit limitation | 56,459,000 | 0 | 0 |
Other | 45,000 | 105,000 | 201,000 |
Total income tax expense | $ 808,000 | $ 0 | $ 0 |
Component of Deferred Tax Asset
Component of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 155,503 | $ 224,161 |
Research credit carryforwards | 12,870 | 28,578 |
Lease Liability | 8,515 | |
Stock Compensation | 5,798 | |
Accruals and reserves | 5,792 | 17,264 |
Other | 212 | 3,250 |
Total deferred tax assets | 188,690 | 273,253 |
Less valuation allowance | (179,253) | (266,100) |
Net deferred tax assets | 9,437 | 7,153 |
Deferred tax liabilities: | ||
Fixed assets | (3,283) | (275) |
Operating lease right-of-use assets | (6,124) | (6,878) |
Other | (30) | |
Total deferred tax liabilities | (9,437) | (7,153) |
Net deferred tax assets | $ 0 | $ 0 |
Schedule of Unrecognized Tax Be
Schedule of Unrecognized Tax Benefits (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Income Tax Disclosure [Abstract] | |
Balance at December 31, 2020 | $ (10,565) |
Tax positions related to the current year, Additions | (308) |
Tax positions related to the current year, Reductions | 0 |
Tax positions related to the prior year, Additions | 0 |
Tax positions related to the prior year, Reductions | 5,258 |
Tax positions related to the prior year, Settlements | 0 |
Tax positions related to the prior year, Lapses in statute | 0 |
Balance at December 31, 2021 | $ (5,615) |